eligibility_summary
Eligible: ages 3-70 with relapsed/refractory T-ALL/LBL, CD7+, >=5% marrow blasts, adequate renal/hepatic function, LVEF >=50%, O2 sat >=92%, ECOG 0-2, expected survival >3 months, consent. Exclude: marrow-failure syndromes, isolated extramedullary disease, key cardiac issues, uncontrolled CNS leukemia, significant neuro hx, other malignancy, immune deficiency, active infections (incl. HIV/HBV/HCV/syphilis), recent anticancer therapy or steroids, acute GvHD, recent live vaccine, allergy, pregnancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05923541 (Henan Cancer Hospital), completed, early phase 1. Intervention: RD13-02 cell infusion—an off‑the‑shelf (“universal”) CD7‑directed chimeric antigen receptor T‑cell (CAR‑T) therapy, single IV dose of 2×10^8 CAR+ T cells. Mechanism: Engineered T cells express a CAR that binds CD7 on target cells, triggering CAR signaling (e.g., via CD3ζ/co‑stimulatory domains) to activate cytotoxic effector functions (perforin/granzyme release, cytokine signaling) and kill CD7+ cells. Targets: CD7 antigen on malignant T cells in relapsed/refractory T‑ALL/LBL, impacts CD7+ T‑lymphoblasts (and may affect normal CD7+ T cells). Study focus: safety and cellular pharmacokinetics (expansion/persistence) of CD7 CAR‑T.