eligibility_summary
Inclusion: 18–75, ECOG 0–1, ≥12‑wk expectancy, recurrent/metastatic MAGE‑A4+, HLA‑A02+ solid tumor post ≥1 therapy, no SOC, measurable lesion, adequate organs & venous access, toxicities ≤G1, contraception, WOCBP negative pregnancy tests. Exclusion: pregnancy, active infections incl HIV/HBV/HCV/COVID, active CNS mets or steroid use, recent other cancer, autoimmune needing systemic Tx, prior CGT/organ transplant, recent bleed/GI ulcer or anticoag, allergy to drug, noncompliance, no washout.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: JWTCR001, an autologous, humanized MAGE‑A4‑directed TCR‑engineered T‑cell therapy (cell/gene therapy) for advanced solid tumors with MAGE‑A4 expression and HLA‑A02. Preconditioning: lymphodepleting fludarabine (purine analog antimetabolite) and cyclophosphamide (alkylating agent) to enhance T‑cell engraftment/expansion. Mechanism: infused T cells express a humanized TCR that recognizes MAGE‑A4 peptides presented by HLA‑A02 on tumor cells, activating TCR signaling, cytokine release, and cytotoxic killing (perforin/granzyme). Targets: tumor cells expressing the cancer‑testis antigen MAGE‑A4, MHC class I antigen‑presentation pathway (HLA‑A02–restricted), tumor immune milieu via lymphodepletion (reducing regulatory/competing lymphocytes).