eligibility_summary
Procurement: CD7>98% T-ALL/LL with BM/CNS/extramedullary relapse or refractory disease (incl post-HSCT >=100 d), age 0.5-25, KPS/Lansky >=60, consent, apheresis access. Exclude active infections, HIV/HBV/HCV, PB blasts >5%, & recent steroids/chemo/nelarabine/daratumumab/clofarabine/ATG/alemtuzumab/immunosuppression/radiation/investigational. Treatment: + measurable disease & HSC donor. Exclude pregnancy, life-exp <6 wks, hepatic/renal/cardiac/O2 failure, seizures/ICP, active GVHD, product contamination.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD7-CART01, a biological, autologous anti-CD7 chimeric antigen receptor T-cell (CAR-T) therapy. Given as a single IV infusion after lymphodepleting chemotherapy (fludarabine/cyclophosphamide). Phase I/II single-arm trial with dose escalation: 0.5–1×10^6 CAR+ cells/kg (with possible 0.25×10^6 if dose-limiting toxicities). Mechanism of action: patient T cells are engineered to express a CAR that binds CD7, engagement triggers CAR signaling (CD3ζ/costimulatory domains) to activate cytotoxic pathways (perforin/granzyme) and cytokine release, killing CD7+ target cells. Targets: CD7 antigen on malignant T-ALL/T-LL blasts, on-target effects also deplete normal CD7+ T cells (and some NK cells). Pathway/cell focus: CD7 surface receptor on T-lineage cells and CAR-T effector activation pathways.