eligibility_summary
Eligible: age ≥2, CD1a+ blasts ≥20%, R/R T-ALL/LL with disease or MRD ≥1e-4 after ≥2 lines (post-allo-HSCT relapse, primary refractory after 2 lines, refractory first relapse, ≥2nd relapse), effective contraception or non-fertile. Exclude: major organ dysfunction (incl LVEF<45%), allo-HSCT <3 mo or on GvHD immunosuppression, uncontrolled CNS/epilepsy, uncontrolled infection, HIV/active HBV/HCV, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: OC-1 (hCD1a-CAR T), an autologous, gene‑modified cellular immunotherapy. Type: CAR T-cell therapy, patient T cells are expanded and transduced with a lentiviral vector to express a CD1a‑specific chimeric antigen receptor. Mechanism of action: The CAR binds CD1a on target cells, antigen engagement triggers CAR signaling (CD3ζ with costimulatory costim domains), driving T‑cell activation, proliferation, cytokine release, and perforin/granzyme‑mediated cytotoxicity, independent of HLA, to kill malignant cells. Cells/pathways targeted: CD1a antigen on CD1a‑positive T‑ALL/LBL blasts, immune effector pathways include CAR‑mediated T‑cell activation and cytolytic pathways that eradicate CD1a‑expressing leukemic/lymphoma cells. Dose-escalation, single-arm Phase 1 study in R/R CD1a+ T‑ALL/LL.