Phase I/Ib Study of NK Cells Expressing an Affinity-Enhanced T-CellReceptor Against NY-ESO-1 in Advanced Synovial Sarcoma andMyxoid/Round Cell Liposarcoma
Trial ID: NCT06083883
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