eligibility_summary
Eligibility: Adults 18–70 with metastatic/recurrent, refractory solid tumors, measurable disease, NY‑ESO‑1 positive, HLA‑A2+, ECOG 0–1, survival >3 mo, adequate organ function, LVEF >45%, contraception, apheresis feasible. Exclude: pregnancy, recent trials, recent malignancy, CNS disease, autoimmune disease/immunosuppression/HIV, thromboembolism/bleeding/CV disease, active infection (incl TB, HBV/HCV), recent surgery/live vaccine, substance abuse, prior cell or NY‑ESO‑1 therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Phase I single-arm trial in HLA-A2+, NY-ESO-1+ advanced solid tumors. Interventions: TC-N201 (biological, autologous TCR-T cells engineered with an NY-ESO-1–specific, HLA-A2–restricted TCR) to recognize and kill NY-ESO-1–expressing tumor cells via TCR-mediated cytotoxicity, IL-2 (cytokine) post-infusion to support in vivo T-cell expansion/persistence, fludarabine (antimetabolite, purine analog) and cyclophosphamide (alkylating agent) plus nab-paclitaxel (albumin-bound taxane) as non-myeloablative lymphodepletion. Targets/pathways: tumor cells presenting NY-ESO-1 peptides on HLA-A2, TCR signaling and cytotoxic effector pathways (perforin/granzyme), IL-2/IL-2R signaling, chemo-induced depletion of endogenous lymphocytes/Tregs and microtubule inhibition in dividing cells.