eligibility_summary
Eligibility: Age 3–70 with r/r T‑ALL/LBL, CD7+, ≥5% marrow blasts, adequate organs (CrCl ≥60 mL/min, ALT/AST <3×ULN, bilirubin <1.5×ULN/≤1.5 mg/dL), LVEF ≥50%, O2 sat ≥92%, ECOG 0–2, >3‑mo survival, consent. Exclude: marrow‑failure syndromes, significant cardiac/neurologic disease, other malignancy, primary immune deficiency, uncontrolled infection, prior anticancer therapy before CAR‑T, systemic steroids, live vaccine <4 wks, HIV/HBV/HCV/syphilis, acute GvHD, product allergy, pregnancy, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: RD13-02 CD7 CAR-T cells (autologous, gene‑modified T‑cell therapy). Mechanism: patient T cells are engineered with a chimeric antigen receptor that binds CD7, antigen engagement triggers T‑cell activation, expansion, cytokine release, and cytolytic killing of CD7+ cells. Targets: CD7 antigen on malignant T‑lymphoblasts in r/r T‑ALL/T‑LBL, on‑target effects also impact normal CD7+ T cells and NK cells. Pathways/cells affected: CAR‑mediated T‑cell activation signaling and cytotoxic effector pathways directed against CD7‑expressing T‑lineage cells. Single‑arm early phase I assessing safety and cellular PK.