Making complex easier to understand.
We are dedicated to sharing comprehensive information about clinical trials and studies related to Synovial Sarcoma. To make these complex details easier to understand, we provide simplified, layman-friendly descriptions. However, we encourage you to visit the official trial links for the most accurate and up-to-date information.
While we strive to update this page regularly, please note that it is not monitored daily.
Trial Status
Eligibility
Phase
Age Group
Treatment Centers
Active Trials
Phase: Not Applicable
Status: Recruiting
Last Update Posted: Please verify directly on ClinicalTrials.gov
Eligibility: Males and females of any age with a reported diagnosis of synovial sarcoma. Informed consent is required from the participant (aged 18 and older) or a parent or guardian for younger participants. No travel is required to participate.
Overview: The Synovial Sarcoma Registry and Biorepository is the only registry dedicated exclusively to synovial sarcoma. By securely collecting medical information, imaging, and tissue samples, the registry enables researchers to better understand the disease, identify new treatment opportunities, and accelerate the development of more effective therapies. Following enrollment, participants share access to their medical records and may provide a blood or saliva sample. Tumor tissue from clinically indicated procedures may also be collected at no additional burden to the patient. Participants may be contacted every 6 to 12 months for treatment and outcome updates for up to 10 years. Genetic testing may be performed on submitted samples, and results will be returned if deemed clinically significant. All coordination is managed entirely by the CHOP study team at no cost to the patient or institution.
Surgery Note: If surgery is planned, patients should enroll before the procedure so that residual tumor tissue may be collected for research.
Why This Matters: Every patient who joins helps build the knowledge base needed to improve outcomes for current and future generations facing synovial sarcoma. This is one of the most impactful things a synovialnsarcoma patient can do to contribute to research, regardless of where they live or what stage of treatment they are in.
Current Stats: 150+ participants enrolled | 2,000+ imaging studies contributed | 70+ blood specimens collected
To Enroll: redcap.chop.edu/surveys/?s=CA89R49CP7AEXMPY
Study Contact:
- Email: SynovialSarcomaRegistry@chop.edu
- Phone: +1 267-827-8145
Treatment Centers:
- Children’s Hospital of Philadelphia, Philadelphia, PA (coordinating site)
- Open to participants worldwide, no travel required
More Information: clinicaltrials.gov/study/NCT05910307 | SSF Registry Page
Phase: Phase 1/2
Status: Active but not recruiting
Last Verified: June 2026
Please Note: This trial is no longer enrolling new patients but remains active. Patients interested in similar approaches should speak with their oncologist or check clinicaltrials.gov for related open studies.
Eligibility: Adults aged 18 and older with advanced solid tumors, including synovial sarcoma, that have not responded to standard treatments. Patients must have tumors that can be directly injected and have adequate organ function.
Overview: This study tests AdAPT-001, a virus injected directly into tumors to attack cancer cells and wake up the immune system. The virus blocks a protein called TGF-β, which sarcoma tumors use to hide from the immune system and resist treatment. Some patients also receive a checkpoint inhibitor drug alongside the virus to further boost the immune response. The FDA has granted this treatment Fast Track designation.
Preliminary Effectiveness: Among 14 soft tissue sarcoma patients who received AdAPT-001 combined with a checkpoint inhibitor, 35.7% had an objective response and 69.2% reached three months without disease progression. Side effects have been mostly mild, including flu-like symptoms and injection site pain.
Treatment Centers:
United States
- MD Anderson Cancer Center, Houston, TX
- Cleveland Clinic, Cleveland, OH
- City of Hope, Duarte, CA
- California Cancer Associates for Research & Excellence, San Diego, CA
- Mary Crowley Cancer Research, Dallas, TX
- Saint John’s Cancer Institute at Providence Saint John’s Health Center, Santa Monica, CA
Phase: Phase 2
Status: Active but not recruiting
Last Update Posted: February 2026
Please Note: This trial is no longer enrolling new patients but remains active for long-term follow-up of enrolled participants.
Eligibility: Patients aged 10 to 75 years with advanced synovial sarcoma who previously received an anthracycline or ifosfamide-containing chemotherapy regimen, have measurable disease, are positive for HLA-A*02:01, -A*02:02, -A*02:03, or -A*02:06, and whose tumor shows MAGE-A4 expression confirmed by central laboratory testing.
Overview: This ongoing study evaluates afamitresgene autoleucel (afami-cel), commercially known as Tecelra, a treatment using patients’ own genetically modified T-cells to target and destroy synovial sarcoma cells expressing the MAGE-A4 antigen. Patients first undergo chemotherapy to prepare the body for treatment, after which their genetically modified T-cells are infused back into their bloodstream to specifically attack the cancer cells. This continuing study aims to confirm long-term effectiveness, safety, and potential side effects in enrolled participants. Principal Investigator: Dejka Araujo, MD, MD Anderson Cancer Center.
Preliminary Effectiveness: Results published in The Lancet (April 2024) confirmed meaningful and durable tumor responses in patients with advanced synovial sarcoma who had previously received chemotherapy. Long-term follow-up is estimated to continue through April 2038, tracking overall survival and duration of response in enrolled patients.
Treatment Centers: USA, Canada, France, Spain, UK
Phase: Phase 2
Status: Recruiting
Last Update Posted: July 2024
Please Note: The estimated primary completion date for this trial was September 2025 and study completion December 2025. We recommend contacting the study team directly to confirm current recruitment status before pursuing enrollment.
Eligibility: Adults aged 18 and older with a confirmed diagnosis of locally advanced, unresectable or metastatic sarcoma who have previously received treatment and have measurable disease. Patients must have adequate cardiac, liver, renal, and blood count function and an ECOG performance status of 2 or below.
Overview: This Phase 2 trial tests a combination of three chemotherapy drugs, gemcitabine, doxorubicin, and docetaxel, given intravenously on Days 1 and 8 of each three-week cycle. After the first cycle, nivolumab (Opdivo), an immune checkpoint inhibitor, is added to the regimen. The goal is to evaluate whether this chemo-immunotherapy combination can slow or stop disease progression in patients with advanced sarcoma who have already received prior treatment. Patients may continue treatment for up to one year. Principal Investigator: Sant P. Chawla, MD, Sarcoma Oncology Research Center, LLC.
Preliminary Effectiveness: The primary goal of the study is to measure progression-free survival at 12 months. Secondary goals include overall response rate assessed at 6 weeks and incidence of treatment-related side effects over 12 months. No formal results have been posted to ClinicalTrials.gov at this time.
Study Contact:
- Sant P. Chawla, MD: santchawla@sarcomaoncology.com / 310-552-9999
- Victoria Chua-Alcala: vchua@sarcomaoncology.com / 310-552-9999
Treatment Centers:
United States
- Sarcoma Oncology Research Center, Santa Monica, CA
Phase: Phase 1
Status: Recruiting
Last Update Posted: January 2026
Eligibility: Adults aged 18 and older with unresectable or metastatic synovial sarcoma who are HLA-A*02:01 positive, have measurable disease and adequate organ function, and have received or declined at least one prior line of treatment.
Overview: This Phase 1 first-in-human trial evaluates IMA203 (anzutresgene autoleucel), a TCR-T cell therapy targeting PRAME, in combination with mRNA-4203, an mRNA-based therapy designed to sustain and expand the engineered T-cells. Patients first receive lymphodepleting chemotherapy, followed by a single infusion of IMA203. Starting Day 15, mRNA-4203 is given over 12 treatment cycles to keep T-cells active. The trial aims to establish a safe dose and evaluate early anti-tumor activity.
Preliminary Effectiveness: As an early Phase 1 trial, no results have been posted yet. The study will evaluate response rate, duration of response, disease control rate, and progression-free survival at one year post infusion.
Study Contact: Immatics US, Inc.
- Phone: +1 346 204-5400
- Email: ctgovinquiries@immatics.com
Treatment Centers:
United States
- University of California San Francisco, San Francisco, CA
- Dana-Farber Cancer Institute, Boston, MA
- Memorial Sloan Kettering Cancer Center, New York, NY
- MD Anderson Cancer Center, Houston, TX
Phase: Phase 1
Status: Recruiting
Last Update Posted: July 2025
Eligibility: Adults aged 18 and older with advanced or metastatic synovial sarcoma who are HLA-A*02 positive, have measurable disease, and have relapsed from, are refractory to, or cannot tolerate standard therapies.
Overview: This first-in-human Phase 1 trial evaluates DS-2243a, an investigational immunotherapy that engages the body’s T-cells to attack tumor cells expressing the NY-ESO-1 protein. The trial includes a dose-escalation phase to establish a safe dose, followed by a dose-expansion phase with a dedicated synovial sarcoma and myxoid/round cell liposarcoma cohort.
Preliminary Effectiveness: As an early Phase 1 trial, the primary goals are safety and optimal dosing. No results have been posted to ClinicalTrials.gov at this time.
Study Contact: Daiichi Sankyo
- Phone: 908-992-6400
- Email: CTRinfo_us@daiichisankyo.com
Treatment Centers: USA, Belgium, France, Netherlands, South Korea
Phase: Phase 1 (dose escalation and expansion)
Status: Other, Not yet recruiting
Last Update Posted: December 2024
Eligibility: Adults aged 18 and older with advanced synovial sarcoma, myxoid/round cell liposarcoma, gastric cancer, or ovarian cancer whose tumors express NY-ESO-1 and/or LAGE-1a and are HLA-A*02:01 positive. Patients must have exhausted standard treatment options.
Overview: This Phase 1 trial evaluates MDG1015, a third-generation TCR-T cell therapy using a patient’s own T-cells engineered to target NY-ESO-1 and LAGE-1a antigens. MDG1015 incorporates a PD1-41BB costimulatory switch protein designed to overcome immune suppression by converting the tumor’s “stop” signal into an activation signal for the T-cells. The trial begins with dose escalation to establish safety and optimal dosing, followed by an expansion phase to evaluate early anti-tumor activity. Principal Investigator: David Zhen, MD, Fred Hutch Cancer Center.
Preliminary Effectiveness: Preclinical studies have demonstrated potent tumor-killing activity by MDG1015, including against tumors with high PD-L1 expression, and improved T-cell fitness through a streamlined 6-day manufacturing process. These findings, alongside results from earlier NY-ESO-1-targeted therapies, suggest MDG1015 could induce strong and durable anti-tumor responses.
Study Contact: Medigene AG
- Kirsty Crame, MD: k.crame@medigene.com / +49 892 000 330
- Marianne Seibt: m.seibt@medigene.com
Treatment Centers:
United States
- Fred Hutch Cancer Center, Seattle, WA
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: January 2026
Eligibility: Adults aged 18 and older with metastatic and/or unresectable soft tissue sarcoma, including synovial sarcoma, who have received at least one but no more than two prior lines of chemotherapy and have measurable disease.
Overview: This first-in-human Phase 1/2 trial evaluates ADCE-D01, an antibody-drug conjugate (ADC) that combines an antibody targeting the uPARAP protein found on sarcoma cells with a topoisomerase I inhibitor designed to kill those cells. ADCE-D01 is given as a weekly intravenous infusion. The trial begins with dose escalation to establish safety and the recommended dose, followed by an expansion phase to evaluate anti-tumor activity including response rate, duration of response, and progression-free survival.
Preliminary Effectiveness: As an early-stage Phase 1/2 trial, no results have been posted to ClinicalTrials.gov at this time. The study aims to evaluate response rate, duration of response, progression-free survival, and clinical benefit rate.
Study Contact: Adcendo ApS
- René Smrčka: rene.smrcka@adcendo.com / +45 3144 0653
- Margaret McNaull: margaret.mcnaull@adcendo.com / +44 7818 457619
Treatment Centers: USA, Belgium, France, Germany, UK
Phase: Phase 1
Status: Recruiting
Last Update Posted: May 2026
Eligibility: Adults aged 18 to 75 with inoperable locally advanced or metastatic synovial sarcoma, ovarian cancer, squamous non-small cell lung cancer, or head and neck cancer who are HLA-A*02:01 positive and whose tumors express the MAGE-A4 protein above a defined threshold. Synovial sarcoma patients must have received at least one prior line of therapy. Patients must have measurable disease and an ECOG performance status of 0 or 1.
Overview: This first-in-human Phase 1 trial evaluates ZI-MA4-1, a first-of-its-kind allogeneic TCR-NK cell therapy. Unlike standard T-cell therapies that use a patient’s own cells, ZI-MA4-1 uses donor-derived Natural Killer (NK) cells engineered with a T-cell receptor targeting MAGE-A4, allowing for an off-the-shelf approach that does not require individual cell collection from each patient. Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide before receiving ZI-MA4-1 via intravenous infusion three times per treatment cycle, for up to two cycles. The trial has two parts: dose escalation to establish the maximum tolerated dose, followed by an expansion phase to further evaluate the recommended dose across one or more indications.
Preliminary Effectiveness: As a first-in-human Phase 1 trial, no results have been posted to ClinicalTrials.gov at this time. The study will evaluate objective response rate, disease control rate, best overall response, and long-term safety up to five years.
Study Contact: Zelluna Immunotherapy AS
- Phone: +47 413 80 080
- Email: ctinfo@zelluna.com
Treatment Centers: UK
Phase: Phase 2
Status: Recruiting
Last Update Posted: January 2024
Eligibility: Patients aged 14 to 70 with advanced or unresectable soft tissue sarcoma, including synovial sarcoma, who have failed or cannot tolerate standard treatment and have at least one measurable lesion. Patients must have an ECOG performance status of 0-1 and adequate organ function.
Overview: This Phase 2 randomized trial compares adriamycin and ifosfamide chemotherapy combined with sintilimab, a PD-1 checkpoint inhibitor, against chemotherapy alone as second-line treatment for patients with advanced or unresectable soft tissue sarcoma. The study aims to determine whether adding sintilimab to standard chemotherapy can improve outcomes for patients whose disease has progressed or who cannot tolerate first-line therapy.
Preliminary Effectiveness: The primary goal is overall response rate at 24 months. Secondary goals include progression-free survival, disease-free survival, and overall survival. No results have been posted to ClinicalTrials.gov at this time.
Study Contact: Xing Zhang
- Phone: 020-87343383
- Email: zhangxing@sysucc.org.cn
Treatment Centers: China
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: October 2025
Eligibility: Adults aged 18 to 70 with metastatic or locally advanced refractory cancer, including synovial sarcoma, whose tumors express the NY-ESO-1 antigen and who are HLA-A*02:01 or A*02:06 positive. Patients must have measurable disease, have received at least one prior line of standard therapy, and have an ECOG performance status of 0-2.
Overview: This Phase 1/2 trial evaluates HBI 0201-ESO TCRT, a TCR-engineered T-cell therapy in which a patient’s own T-cells are genetically modified to recognize and attack NY-ESO-1-expressing cancer cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by a single infusion of the engineered T-cells and low-dose interleukin-2 to support T-cell persistence. Part A establishes the maximum tolerated dose across three dose levels, and Part B expands enrollment at the safe dose to evaluate clinical response rates.
Preliminary Effectiveness: As an early-stage Phase 1/2 trial, no results have been posted to ClinicalTrials.gov at this time. The study aims to evaluate safety, objective tumor regression, and persistence of the transferred T-cells in the blood over five years.
Study Contact: Hadassah Medical Organization
- Michal Lotem, Prof.: mlotem@hadassah.org.il / +972 508 573 528
- Yafit Halutsi: yafitha@hadassah.com / +972 526 906 339
Treatment Centers: Israel
Phase: Phase 1
Status: Other, Unknown
Last Update Posted: October 2018
Please Note: This trial’s status has not been updated since October 2018. The primary completion date was September 2018 and enrollment has closed with 9 patients enrolled. Patients should contact the study team directly to confirm current status before pursuing enrollment.
Eligibility: Adults aged 20 and older with unresectable solid tumors, including synovial sarcoma, that are refractory to standard therapy, are HLA-A*02:01 or HLA-A*02:06 positive, and whose tumors express the NY-ESO-1 antigen confirmed by PCR or immunohistochemistry. Patients must have an ECOG performance status of 0-1.
Overview: This Phase 1 trial evaluates TBI-1301, a TCR gene therapy in which a patient’s own T-cells are genetically modified to target NY-ESO-1-expressing cancer cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide alone or in combination with fludarabine, followed by a single infusion of the engineered T-cells. The primary objectives were to evaluate safety, tolerability, and the persistence of transferred T-cells in the blood.
Preliminary Effectiveness: No formal results have been posted to ClinicalTrials.gov. A 2022 publication in the Journal for ImmunoTherapy of Cancer reported that NY-ESO-1 TCR-redirected T-cells showed tumor responses alongside cytokine release syndrome in treated patients, providing early evidence of both activity and immune-related side effects with this approach.
Study Contact: Mie University Hospital, Tsu, Japan
Treatment Centers: Japan
Phase: Phase 2
Status: Recruiting
Last Update Posted: January 2025
Eligibility: Individuals aged 13 to 50 with advanced synovial sarcoma or desmoplastic small round cell tumor expressing somatostatin receptors (SSTR2/3/5) who have completed standard intensive treatment and achieved stable disease, partial, or complete response.
Overview: This Phase 2 trial evaluates pasireotide (Signifor), a long-acting somatostatin analog, as maintenance therapy following standard treatment for synovial sarcoma and desmoplastic small round cell tumor. Somatostatin receptors SSTR2, SSTR3, and SSTR5 are frequently overexpressed in both tumor types, providing the rationale for targeting them after initial chemotherapy, surgery, or radiation. Participants receive monthly pasireotide injections for up to four years. The trial is designed to assess whether this targeted maintenance approach can delay or prevent disease relapse.
Preliminary Effectiveness: The trial aims to determine whether pasireotide can prolong progression-free survival and overall survival in patients with SSTR2/3/5-expressing advanced synovial sarcoma and desmoplastic small round cell tumor. No results have been posted to ClinicalTrials.gov at this time.
Study Contact: University Hospital Heidelberg
- Richard F. Schlenk, Prof.: richard.schlenk@nct-heidelberg.de / +49 6221 56 6228
- Editha Gnutzmann: e.gnutzmann@nct-heidelberg.de / +49 6221 36235
Treatment Centers: Germany
Phase: Phase 1
Status: Active but not recruiting
Last Update Posted: December 2025
Please Note: This trial is no longer enrolling new patients but remains active for follow-up of enrolled participants.
Eligibility: Patients aged 16 and older with metastatic or recurrent unresectable solid tumors, including synovial sarcoma, who are HLA-A*02:01 or HLA-A*02:06 positive and whose tumors express the NY-ESO-1 antigen confirmed by immunohistochemistry. Patients must have measurable disease and an ECOG performance status of 0-1.
Overview: This Phase 1 trial evaluates TBI-1301, a TCR gene therapy in which a patient’s own T-cells are genetically modified to recognize and attack NY-ESO-1-expressing cancer cells. Patients first receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine, followed by an intravenous infusion of the modified T-cells. The study evaluates two approaches: a retreatment cohort for patients who have previously received TBI-1301, and a double infusion cohort in which T-cells are given on Day 0 and again on Day 14.
Preliminary Effectiveness: No formal results have been posted to ClinicalTrials.gov at this time. The study aims to establish a recommended Phase 2 dose and evaluate early signs of anti-tumor activity using RECIST v1.1.
Treatment Centers: Canada
Phase: Phase 2
Status: Recruiting
Last Update Posted: Please verify directly on ClinicalTrials.gov
Eligibility: Adults aged 18 to 75 with advanced or metastatic high-grade soft tissue sarcoma, including synovial sarcoma, whose cancer did not respond to or who cannot tolerate anthracycline chemotherapy. Tumors must test positive for CD13 (a specific protein marker) with a score of 1 or higher, and patients must have at least one measurable lesion not previously treated with radiation.
Overview: This Phase 2 trial compares trabectedin alone versus trabectedin combined with tTF-NGR, an investigational therapy designed to target tumor blood vessels and concentrate drug delivery within the tumor. Participants are randomly assigned to one of two treatment groups and receive treatment by intravenous infusion for up to 360 days. Regular imaging tests monitor tumor response throughout the study. The study is expected to run until March 2029.
Preliminary Effectiveness: Trabectedin has demonstrated activity in soft tissue sarcoma including synovial sarcoma. tTF-NGR is an investigational approach aimed at improving treatment precision by concentrating therapy within the tumor. This study will determine whether the combination offers added benefit over trabectedin alone. No results have been posted at this time.
Treatment Centers: Germany
Phase: Phase 1
Status: Active but not recruiting
Last Update Posted: June 2026
Please Note: This trial is no longer enrolling new patients but remains active for long-term follow-up of enrolled participants.
Eligibility: Adults aged 18 to 75 with advanced synovial sarcoma expressing the MAGE-A4 antigen who are HLA-A*02 positive, have measurable disease, and have progressed after prior standard therapies.
Overview: This Phase 1 trial evaluates MAGE-A4ᶜ¹⁰³²T, a TCR-engineered T-cell therapy in which a patient’s own T-cells are modified to recognize and attack tumor cells expressing MAGE-A4. The trial also includes a radiation sub-study evaluating the combination of MAGE-A4ᶜ¹⁰³²T with low-dose radiation in up to 10 patients who have at least one tumor lesion amenable to radiation.
Preliminary Effectiveness: Results published in Nature Medicine (January 2023) demonstrated an overall response rate of approximately 39% across evaluable patients, with some experiencing significant tumor shrinkage and disease stabilization lasting a median of approximately 12 months, indicating potential durable benefit in this patient population.
Treatment Centers: USA, Canada
Phase: Phase 2
Status: Active but not recruiting
Last Update Posted: April 2026
Please Note: This trial is no longer enrolling new patients but remains active for long-term follow-up of enrolled participants.
Eligibility: Individuals aged 10 and older with unresectable or metastatic synovial sarcoma or myxoid/round cell liposarcoma expressing the NY-ESO-1 antigen who are positive for HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 and have measurable disease. Substudy 1 accepts previously untreated patients; Substudy 2 requires prior anthracycline-based chemotherapy.
Overview: This Phase 2 master protocol evaluates letetresgene autoleucel (lete-cel), a NY-ESO-1-specific TCR-engineered T-cell therapy, across two substudies in patients with advanced synovial sarcoma or myxoid/round cell liposarcoma. Patients first receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by a single infusion of their modified T-cells. Substudy 1 evaluates lete-cel as a first-line treatment, while Substudy 2 evaluates it as second-line or later therapy. The trial enrolled 103 patients across 38 sites in 8 countries.
Preliminary Effectiveness: As of the latest interim analysis, lete-cel demonstrated an overall response rate of 42% among 64 evaluable patients, including 6 complete responses and 21 partial responses. The median duration of response was 12.2 months and median progression-free survival was 5.3 months, indicating meaningful anti-tumor activity in heavily pre-treated patients.
Treatment Centers: USA, Canada, France, Italy, Netherlands, Spain, UK
Phase: Phase 3
Status: Active but not recruiting, (Synovial Sarcoma cohort closed)
Last Update Posted: February 2026
Please Note: The synovial sarcoma cohort of this trial is closed to new enrollment. This trial is currently only recruiting patients with alveolar soft part sarcoma.
Eligibility: Adults aged 18 and older with advanced solid tumors, including synovial sarcoma, whose tumors express the NY-ESO-1 antigen and are HLA-A*02 positive. The synovial sarcoma portion of this trial is no longer recruiting new participants.
Overview: This Phase 3 trial evaluated AL3818 (anlotinib/catequentinib), an oral multikinase inhibitor, in patients with advanced alveolar soft part sarcoma, leiomyosarcoma, and synovial sarcoma. For synovial sarcoma patients, the study compared anlotinib against IV dacarbazine in a 2:1 randomization. Participants with synovial sarcoma were required to have previously received at least one line of standard therapy including first-line anthracycline chemotherapy. The synovial sarcoma cohort has since closed, and the study currently continues only for alveolar soft part sarcoma patients.
Preliminary Effectiveness: Early studies of NY-ESO-1 directed T-cell therapies have shown promising anti-tumor responses in synovial sarcoma, helping pave the way for newer T-cell therapies currently being tested in clinical trials. No formal results for the synovial sarcoma cohort have been posted to ClinicalTrials.gov at this time.
Study Contact: Advenchen Laboratories, LLC
- Shiying: Shiyings@advenchen.com / 805-530-1550
- Judy: judyc@advenchen.com / 805-530-1550
Treatment Centers: USA, China, Italy, Spain, UK
Phase: Early Phase 1
Status: Recruiting
Last Update Posted: June 2026
Eligibility: Adults aged 18 to 80 with synovial sarcoma or myxoid/round cell liposarcoma who have previously received and progressed after T-cell receptor therapy (TCR-T), including FDA-approved afamitresgene autoleucel (Tecelra) or similar products targeting MAGE-A4, PRAME, or NY-ESO-1. Patients must have shown at least some clinical benefit on at least one scan after their prior T-cell therapy and have measurable disease.
Overview: This pilot Phase 1 trial tests N-803 (nogapendekin alfa inbakicept), an IL-15 superagonist, in patients whose synovial sarcoma has progressed after prior T-cell therapy. Even after T-cell therapy fails, rare tumor-specific T-cells can still be detected in the blood of synovial sarcoma patients. While these surviving T-cells are no longer able to expand or kill tumor effectively on their own, stimulating them with IL-15 may reactivate them into potent cancer-killing agents. N-803 is given by subcutaneous injection every 14 days for up to 52 cycles. Patients also undergo leukapheresis before and during treatment so that researchers can track whether the surviving T-cells are expanding and becoming active again.
Preliminary Effectiveness: N-803 is FDA-approved for bladder cancer, but this is the first trial ever designed to reactivate residual T-cells in synovial sarcoma patients after prior T-cell therapy. Laboratory results showed this to be a highly effective strategy, and this trial will now test whether those findings translate to the clinic. No clinical results have been posted to ClinicalTrials.gov at this time.
Study Contact: Seth M. Pollack, MD, Northwestern University
- Email: seth.pollack@northwestern.edu
- Phone: 312-695-6180
- General inquiries: cancer@northwestern.edu / 312-695-1301
Treatment Centers:
- Northwestern University, Chicago, IL
Phase: Phase 1/2
Status: Recruiting
Last Update Posted: February 2026
Eligibility: Children and young adults aged 2 to 17 with synovial sarcoma who are HLA-A*02 positive, whose tumors express MAGE-A4 confirmed by central laboratory, weigh at least 10 kg, have received prior systemic chemotherapy, and have measurable disease. Good performance status is required (ECOG 0-1 for patients aged 16 and older; Lansky score ≥80 for those under 16).
Overview: This Phase 1/2 pediatric basket study expands the evaluation of afamitresgene autoleucel (afami-cel, Tecelra) to pediatric patients with synovial sarcoma, malignant peripheral nerve sheath tumor, neuroblastoma, and osteosarcoma. As in adult treatment, a patient’s own T-cells are collected, genetically modified to recognize MAGE-A4-expressing cancer cells, and infused back after lymphodepleting chemotherapy. Results for each cancer type are tracked separately. Phase 1 evaluates safety and dose; Phase 2 evaluates anti-tumor activity in the pediatric population.
Preliminary Effectiveness: In adult clinical trials, afami-cel achieved a 39% response rate in advanced synovial sarcoma, leading to its FDA approval. Pediatric data is still emerging. This study aims to determine whether similar efficacy extends to younger patients, with early case reports showing promise.
Treatment Centers: USA
- Stanford University, Palo Alto, CA
- National Institutes of Health, Bethesda, MD
- Dana-Farber Cancer Institute, Boston, MA
- Washington University, St. Louis, MO
- Memorial Sloan Kettering Kids, New York, NY
- Duke University School of Medicine, Durham, NC
- Cincinnati Children’s Hospital Medical Center, Cincinnati, OH
- Children’s Hospital of Philadelphia, Philadelphia, PA
- Seattle Children’s Hospital, Seattle, WA
- University of Wisconsin Cancer Center, Madison, WI
Phase: Phase 1
Status: Recruiting
Last Update Posted: January 2026
Eligibility: Patients aged 1 to 25 with advanced or recurrent synovial sarcoma expressing the HER2 protein who have progressed after at least one prior systemic therapy, have measurable disease, and a Karnofsky or Lansky performance score of at least 60.
Overview: This Phase 1 trial, sponsored by Baylor College of Medicine and led by Principal Investigators Meenakshi Hegde, MD, Shoba Navai, MD, and Nabil Ahmed, MD, investigates HER2-targeted CAR T-cell therapy combined with a checkpoint inhibitor in patients with advanced sarcoma including synovial sarcoma. A patient’s own T-cells are genetically modified to recognize HER2-expressing tumor cells. After lymphodepleting chemotherapy with cyclophosphamide and fludarabine, the modified T-cells are infused back into the patient. Starting one week later, patients receive either pembrolizumab (every three weeks) or nivolumab (every two weeks) to further activate the immune response against the cancer. Patients who tolerate the treatment well may receive additional T-cell infusions at 6 to 12 week intervals.
Preliminary Effectiveness: Early-phase studies of HER2-targeted CAR T-cell therapy in sarcoma have demonstrated safety and some clinical benefit in advanced patients. No formal results for this specific trial have been posted to ClinicalTrials.gov at this time.
Study Contact: Baylor College of Medicine
- Meenakshi Hegde, MD: mghegde@bcm.edu / 832-824-4840
- Brandon Garner: bjgarner@texaschildrens.org / 832-824-4594
Treatment Centers:
- Texas Children’s Hospital, Houston, TX
Phase: Phase 1/Ib
Status: Recruiting
Last Update Posted: April 2026
Eligibility: Patients aged 16 to 80 with histologically confirmed advanced synovial sarcoma who are HLA-A*02:01, HLA-A*02:05, or HLA-A*02:06 positive, whose tumors express NY-ESO-1 in at least 50% of cells, have measurable disease, and have received at least one prior line of systemic therapy including doxorubicin or ifosfamide.
Overview: This Phase 1/Ib trial at MD Anderson Cancer Center, led by Principal Investigator John Livingston, MD, evaluates a novel approach using donor-derived cord blood NK cells genetically engineered to carry an affinity-enhanced T-cell receptor (TCR) targeting NY-ESO-1, enhanced with interleukin-15 (IL-15) to improve their persistence and cancer-killing activity. Unlike standard T-cell therapies that require collection of the patient’s own cells, these are off-the-shelf NK cells from a donor, potentially offering broader accessibility. Patients receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide before the NK cell infusion. The trial tests up to four dose levels to determine the safest and most effective dose.
Preliminary Effectiveness: Similar NK cell-based approaches have shown promising results in laboratory studies. No formal clinical results for this trial have been posted to ClinicalTrials.gov at this time.
Study Contact: John Livingston, MD, MD Anderson Cancer Center
- Phone: 713-792-3626
- Email: jalivingston@mdanderson.org
Treatment Centers:
- MD Anderson Cancer Center, Houston, TX
Phase: Phase 3
Status: Recruiting
Last Update Posted: May 2026
Eligibility: Adults aged 18 and older who are scheduled for surgical resection of a lung lesion or mass with diagnostic or curative intent and are eligible for the planned surgery.
Overview: This Phase 3 trial, sponsored by Vergent Bioscience, Inc., evaluates abenacianine (VGT-309), an investigational fluorescent imaging agent that is administered intravenously 12 to 96 hours before lung surgery. During surgery, near-infrared (NIR) imaging is used to activate the agent, causing tumor cells to “light up” in real time and helping surgeons identify cancer lesions that may not be visible through standard surgical techniques. The study compares standard surgery alone against surgery enhanced with NIR imaging to determine whether the approach improves tumor detection and surgical outcomes. While not a synovial sarcoma-specific trial, this study is relevant to patients with synovial sarcoma who have developed lung metastases and are undergoing surgical resection.
Preliminary Effectiveness: Earlier research suggests tumor-targeted fluorescent imaging may help detect cancer lesions not visible through standard methods. This Phase 3 study aims to confirm whether this approach improves detection and surgical outcomes. No results have been posted to ClinicalTrials.gov at this time.
Study Contact: Vergent Bioscience, Inc.
- Brian York: byork@vergentbio.com / 978-882-1403
- Eric Bensen, PhD: ebensen@vergentbio.com / 952-479-7496
Treatment Centers: USA, Australia
Phase: Phase 2
Status: Recruiting
Last Update Posted: May 2026
Eligibility: Adults aged 18 and older with metastatic or unresectable leiomyosarcoma, bone sarcoma, or translocation-associated soft tissue sarcoma, including synovial sarcoma, who have received at least two prior lines of therapy and no more than two prior tyrosine kinase inhibitors, and have measurable disease.
Overview: This Phase 2 trial, sponsored by Northwestern University and coordinated by Seth Pollack, MD, investigates zanzalintinib (XL092), a next-generation oral tyrosine kinase inhibitor in the same drug family as pazopanib (Votrient). The translocation-associated sarcoma arm of this trial was specifically designed with synovial sarcoma in mind. XL092 is taken once daily in 14-day cycles and is believed to be better tolerated and potentially more effective than similar drugs currently available. The leiomyosarcoma cohort has already completed accrual with encouraging early signals, and enrollment is now open for the synovial sarcoma cohort.
Preliminary Effectiveness: The leiomyosarcoma cohort has shown encouraging early results and the drug appears well tolerated. Efficacy data in synovial sarcoma is still being collected and it is too early to draw conclusions, but researchers are hopeful.
Study Contact: Northwestern University
- Seth Pollack, MD: seth.pollack@northwestern.edu
- Cameron Dubois (Study Coordinator): cameron.dubois@northwestern.edu
Treatment Centers:
- Northwestern University, Chicago, IL
More Information: trialx.com/clinical-trials/listings/300292 | cancer.gov trial
listing
Phase: Phase 1
Status: Recruiting (UK)
Last Update Posted: July 2026
Please Note: Update July 2026: The first patient has been dosed at The Christie NHS Foundation Trust, marking the official start of clinical treatment in ZIMA-101. Initial clinical data is expected to emerge from mid-2026. Learn More: https://zelluna.com/investors/news/zelluna-doses-first-solid-tumour-patient-with-zi-ma4-1-in-the-zima-101-phase-1-trial
Eligibility: Adults aged 18 to 75 with inoperable locally advanced or metastatic synovial sarcoma, ovarian cancer, squamous non-small cell lung cancer, or head and neck cancer who are HLA-A*02:01 positive and whose tumors express the MAGE-A4 protein above a defined threshold. Synovial sarcoma patients must have received at least one prior line of therapy. Patients must have measurable disease and an ECOG performance status of 0 or 1.
Overview: This first-in-human Phase 1 trial (ZIMA-101) evaluates ZI-MA4-1, an allogeneic “off-the-shelf” TCR-NK cell therapy developed by Zelluna ASA. Unlike therapies that use a patient’s own cells, ZI-MA4-1 uses donor-derived NK cells engineered to target MAGE-A4-expressing tumors. Patients receive lymphodepleting chemotherapy, then ZI-MA4-1 by IV infusion across up to two treatment cycles, first to establish a safe dose, then to evaluate its effect.
Preliminary Effectiveness: As a first-in-human trial, no results have been posted yet. The study will track response rate, disease control, and long-term safety over five years.
Study Contact:
Namir Hassan, CEO
- Email: namir.hassan@zelluna.com
- Phone: +44 7720 687608
Geir Christian Melen, CFO
- Email: geir.christian.melen@zelluna.com
- Phone: +47 913 02 965
Treatment Centers:
United Kingdom
- The Christie NHS Foundation Trust, Manchester (active)
- The Royal Marsden (active)
More Information: zelluna.com/investors/news/zelluna-asa-activates-first-clinical-site-for-zima-101-marking-entry-into-clinical-execution | zelluna.com
FDA-Approved or Completed Trials
Phase: Approved
Status: Completed, Available Treatment
Last Verified: June 2026
Eligibility: Adults and pediatric patients aged 12 and older with unresectable or metastatic synovial sarcoma who previously received chemotherapy, are positive for HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P, and whose tumor expresses the MAGE-A4 antigen as confirmed by an FDA-approved companion diagnostic test.
Overview: Tecelra (afamitresgene autoleucel) is the first and only FDA-approved engineered T-cell therapy for a solid tumor, and the first new treatment option for synovial sarcoma in over a decade. A patient’s own white blood cells are collected, genetically engineered to recognize and attack MAGE-A4-expressing synovial sarcoma cells, and infused back in a single one-time treatment. The process, from cell collection to infusion, takes approximately six weeks and is only available at specially trained Authorized Treatment Centers (ATCs).
Preliminary Effectiveness: Based on the SPEARHEAD-1 study of 137 patients, Tecelra showed an overall response rate of 43.8%, with nearly 32% of responding patients maintaining their response for 24 months or longer.
Treatment Centers:
United States
- Memorial Sloan Kettering Cancer Center, New York, NY
- MD Anderson Cancer Center, Houston, TX
- Moffitt Cancer Center, Tampa, FL
- Mayo Clinic, Rochester, MN
- Stanford Health Care, Stanford, CA
- City of Hope, Duarte, CA
- Northwestern Memorial Hospital, Chicago, IL
- Dana-Farber Cancer Institute, Boston, MA
- Massachusetts General Hospital, Boston, MA
- Cleveland Clinic, Cleveland, OH
- Vanderbilt-Ingram Cancer Center, Nashville, TN
Note: Authorized Treatment Centers are regularly updated. Find the most current list at the TECELRA Treatment Center Finder or call AdaptimmuneAssist at 1-855-246-9232.
Terminated/FDA Withdrawn Trials
Phase: Phase 2
Status: Terminated
Last Verified: May 2026
Eligibility: Adults with advanced or metastatic synovial sarcoma confirmed by the SS18-SSX fusion gene. Participants must have measurable tumors and have experienced disease progression after prior therapies.
Overview: This Phase 2 trial investigated tazemetostat, an oral medication that blocks the EZH2 enzyme, which plays a role in the growth of synovial sarcoma. The study aimed to determine whether tazemetostat could slow or stop tumor growth in patients with advanced synovial sarcoma.
Results: No tumor shrinkage was observed in the synovial sarcoma patients enrolled. However, about one-third of patients saw their disease stabilize, with a smaller group maintaining that stability for four months or longer. The drug was generally well tolerated, with the most common side effects being mild
cough, shortness of breath, and fatigue.
⚠️ Important Update – FDA Approval Withdrawn (May 2026) In March 2026, the maker of tazemetostat voluntarily withdrew all FDA approvals for the drug after a clinical trial in another cancer type revealed a serious risk of developing secondary blood cancers, including leukemia and myelodysplastic syndrome, in some patients.
More Information: clinicaltrials.gov/study/NCT02601950
Treatment Centers: USA, Australia, Belgium, Canada, France, Germany, Italy, Taiwan, UK