eligibility_summary
Include: 2–60 y R/R T‑ALL/LBL after ≥2 regimens or post‑HSCT relapse/nonresponse, CD7≥70%, ECOG 0–2, >3‑mo survival, prior tox <G2, adequate organ function, consent. Exclude: tumor load >70% at collection, other malignancy, symptomatic CNS leukemia, active HBV/HCV/HIV/CMV/syphilis, severe allergy to study/LD drugs, serious cardiac/organ/unstable disease, solid organ transplant, active GVHD or HSCT <6 mo, neuro autoimmune/PRES, recent major surgery/live vaccine, pregnancy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT05909527 (Phase 1/2, single-arm). Intervention: Autologous anti-CD7 CAR-T cell therapy (biologic, gene‑modified T‑cell infusion). Single IV infusion after lymphodepletion, dose escalation/expansion at 0.5, 1.0, and 2.0×10^6 CAR-T cells/kg (±20%). Mechanism of action: Patient T cells are engineered to express a chimeric antigen receptor that binds CD7. Upon CD7 engagement, CAR signaling (via activation domains such as CD3ζ with co-stimulation) triggers T‑cell activation, cytokine release, and cytotoxic killing of target cells, leading to apoptosis and clearance of CD7+ cells. Targets (cells/pathways): CD7 antigen on malignant T‑lymphoblasts in relapsed/refractory T‑ALL/LBL, pathway is antigen-dependent CAR signaling leading to elimination of CD7‑expressing T‑lineage cells. Primary aims: safety, tolerability, cell kinetics, and preliminary efficacy.