eligibility_summary
Eligibility: Age 3–70, r/r T‑ALL/LBL/AML, CD7+, ≥5% marrow blasts, ECOG 0–2, CrCl ≥60, AST/ALT <3×ULN, bilirubin <1.5×ULN (≤1.5 mg/dL), LVEF ≥50%, O2 sat ≥92%, survival >3 mo, consent. Exclude: APL or BCR‑ABL+ (CML‑BC), marrow‑failure syndromes, major cardiac/neuro disease, other prior malignancy (except NMSC/carcinoma), immune deficiency, uncontrolled infection incl. HIV/HBV/HCV/syphilis, recent steroids/anticancer therapy/live vaccine, acute GvHD, product allergy, pregnancy, or per investigator.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: RD13-02 CAR-T cell injection (autologous, gene-modified cellular immunotherapy), single infusion of 2×10^8 CAR+ T cells. Mechanism: patient T cells are engineered to express an anti‑CD7 chimeric antigen receptor, CAR binding to CD7 triggers CD3ζ/costimulatory signaling, leading to MHC‑independent activation, expansion, cytokine release, and perforin/granzyme‑mediated killing. Targets: CD7 on malignant T cells in r/r T‑ALL/LBL and CD7‑positive AML blasts, expected on‑target depletion of normal CD7+ T/NK cells (T‑cell aplasia). Pathways: CAR signaling and immune effector cytotoxic/apoptotic pathways.