Trial Status
Eligibility
Phase
Age Group
Treatment Centers
Active Trials
Trial ID: NCT05448820
Phase: 1/2
Status: Recruiting
Eligibility: Measurable tumor necessary
Age Group: Adult
Overview: This trial investigates the effectiveness of dual immune checkpoint inhibition therapy, combining envafolimab (an antibody targeting PD-L1) and YH001 (an antibody targeting CTLA-4), either alone or with the chemotherapy drug doxorubicin. The study aims to determine whether combining these treatments can effectively activate the immune system to recognize, attack, and shrink advanced synovial sarcoma tumors resistant to standard therapies.
Preliminary Effectiveness: This combination immunotherapy approach has demonstrated promising early results in initial evaluations, showing potential for improved tumor control compared to single checkpoint inhibition alone. Early evidence from related trials suggests dual checkpoint inhibition could enhance the body’s anti-tumor immune response.
Trial ID: NCT06083883
Phase: 1/Ib
Status: Recruiting
Eligibility: Patients aged 16–80 with advanced synovial sarcoma expressing the NY-ESO-1 antigen and HLA-A*02 positive. Patients must have tumors that have progressed despite standard treatments.
Age Group: 16-80
Overview: This clinical trial evaluates a novel immunotherapy approach using natural killer (NK) cells genetically engineered to target NY-ESO-1, a protein commonly expressed by synovial sarcoma tumor cells. These modified NK cells are enhanced with interleukin-15 (IL-15) to improve their ability to persist and effectively destroy cancer cells. Patients receive chemotherapy conditioning before infusion of the engineered NK cells, which are designed to specifically recognize and attack tumors.
Preliminary Effectiveness: Although results from this specific study are pending, similar NK cell-based therapies have demonstrated promising early effectiveness in laboratory studies and initial clinical settings, showing potential for meaningful tumor responses.
FDA-Approved or Completed Trials
Phase: 2
Status: Active but not recruiting
Eligibility: Patients with NY-ESO-1-positive synovial sarcoma.
Overview: Letetresgene autoleucel is a T-cell therapy targeting the NY-ESO-1 antigen, which is commonly found in synovial sarcoma. This therapy involves modifying patients’ T-cells to recognize and attack NY-ESO-1-expressing tumor cells. It has shown promising results in trials and is now FDA-approved for use in patients with synovial sarcoma who have this specific marker.
Trial ID: NCT04044768
Phase: Approved
Status: Available Treatment
Eligibility: Adults with unresectable or metastatic synovial sarcoma expressing the MAGE-A4 antigen who previously received chemotherapy and are positive for HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P.
Age Group: Adults
Overview: Afamitresgene autoleucel (Tecelra) is an FDA-approved immunotherapy using patients’ own genetically engineered T-cells to specifically recognize and attack synovial sarcoma cells expressing the MAGE-A4 antigen. Patients undergo lymphodepleting chemotherapy before modified T-cells are infused back into their bloodstream. This ongoing post-approval study aims to confirm long-term effectiveness, safety, and potential side effects as required by the FDA for therapies granted accelerated approval.
Preliminary Effectiveness: Clinical trials demonstrated a 39% overall response rate, with responses lasting a median of approximately 12 months. Patients experienced significant tumor shrinkage and sustained disease stabilization in advanced synovial sarcoma previously resistant to other treatments.
Terminated Trials
Phase: 1/2
Status: Terminated
Eligibility: Patients with SMARCB1-perturbed cancers, including synovial sarcoma.
Age Group: Any
Overview: This trial investigated CFT8634, a potential treatment designed to target BRD9, a protein that plays a role in cancer cell growth. Unfortunately, it was terminated due to lack of clinical benefit, as it did not meet the necessary criteria to continue development for synovial sarcoma.
Preliminary Effectiveness: n/a
Phase: 1
Status: Terminated
Eligibility: Patients with SMARCB1-mutated tumors, including synovial sarcoma.
Age Group: Any
Overview: This study aimed to test FHD-609, a drug designed to degrade the BRD9 protein in cancer cells. However, after early trials, the study was terminated because the drug did not show sufficient benefit for patients with synovial sarcoma and similar cancers.