eligibility_summary
Inclusion: HLA‑A02:01/02:05/02:06+ and NY‑ESO‑1 ≥50% by IHC (MDACC). Dose‑esc: advanced solid tumors, expansion: synovial sarcoma or MRCLS. Relapsed/refractory after SOC, RECIST‑measurable. Washouts apply. ECOG 0–1, adequate organs, age 16–80, ≥40 kg, contraception and negative pregnancy test. Exclusion: unresolved ≥G2 toxicity, active HBV/HCV/HIV, autoimmune or neurologic disease, uncontrolled CNS mets, serious cardiac/QTc>470, immunosuppression or steroids>10 mg, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: NY-ESO-1 TCR/IL-15 NK—an allogeneic, cord blood–derived, gene-modified NK cell therapy given IV. These NK cells express an affinity-enhanced TCR specific for NY-ESO-1 peptide presented by HLA-A02 and are engineered to produce IL-15. Mechanism: TCR redirection enables recognition and killing of NY-ESO-1+ tumor cells, autocrine IL-15 supports NK survival, proliferation, and persistence. Lymphodepleting chemotherapy: fludarabine phosphate (IV purine analog/antimetabolite) and cyclophosphamide (IV alkylating agent) to reduce host lymphocytes, enhance engraftment, and debulk tumor. Targets/pathways: NY-ESO-1 cancer-testis antigen on HLA-A2+ synovial sarcoma and myxoid/round cell liposarcoma cells, TCR signaling in engineered NK cells, IL-15/STAT5 signaling, lymphodepletion of competing/regulatory immune cells. Status: Phase I/Ib dose escalation.