eligibility_summary
Inclusion: Adults 18–75 with r/r T‑LBL/ALL: relapse (>5% blasts/extramedullary) or refractory after ≥2 inductions/failed salvage, CD7+, if PB blasts, CD4/CD8 double‑neg, ECOG 0–2, life expectancy >12 wk, Hgb ≥70, PLT ≥50×10^9/L, LVEF ≥50%, O2 ≥92%, adequate liver/renal. Exclusion: serious cardiac/QTc>480, allo‑HSCT <6 mo, active GvHD/immunosuppression, other recent cancers, CNS disease, active infection (HBV DNA+, HCV RNA+, HIV, CMV, syphilis), autoimmune on systemic tx, recent trial, severe biologic allergy, unstable dz, pregnancy/breastfeeding or plans ≤2 y, prior CAR‑T/gene‑mod cells.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: SENL101, an autologous CD7-directed CAR-T cell therapy (gene‑modified cellular immunotherapy/biologic). Mechanism: patient T cells are engineered to express a CAR that binds CD7, antigen engagement triggers CAR signaling and cytotoxic effector functions to eliminate CD7+ malignant T lymphoblasts. Targets: CD7 on T‑LBL/ALL cells, on‑target effects also deplete normal CD7+ T and NK cells, with immune reconstitution assessed. Study: Phase 1, open‑label, dose‑escalation, single arm in adults with relapsed/refractory T‑LBL/ALL, endpoints include safety/tolerability, preliminary efficacy, PK/PD, immunogenicity, and T/NK recovery.