eligibility_summary
Adults 18–70 with CD19+ B‑ALL/LBL, aggressive or indolent B‑NHL meeting R/R or early‑relapse criteria (incl Ph+ after >2 TKIs). Needs CD19 ≥20% (ALL)/positive (lymphoma), ECOG 0–2, ≥12‑wk expectancy, CD3+ >0.1×10^9/L, adequate organ function, contraception if fertile, 15‑yr follow‑up, consent. Exclude: low/no CD19, active HBV/HCV/HIV/COVID or infection, low CD3+, prior gene therapy, major CNS/cardiac disease, genetic syndromes, pregnancy, prohibited meds/recent trials, poor adherence.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase I/II single-arm trial of Hem101 (Hemagenleukleucel), an autologous, second-generation anti‑CD19 CAR‑T cell therapy (gene‑modified cellular immunotherapy/biologic) for relapsed/refractory B‑cell malignancies (B‑ALL, B‑cell NHL). After lymphodepleting chemotherapy, patients receive two IV infusions. Mechanism: patient T cells are engineered to express a chimeric antigen receptor that binds CD19 on B cells and signals via CD3ζ plus a costimulatory domain (typical of 2nd‑gen CARs), driving T‑cell activation, expansion, cytokine release, and cytotoxic killing of CD19+ tumor cells, often causing B‑cell aplasia. Targets: CD19+ B‑cell lineage, pathways engaged include CAR/TCR signaling and downstream cytotoxic/cytokine programs, disease biology centers on the B‑cell co‑receptor CD19 axis. Primary endpoint: Day‑28 ORR, key safety risks monitored include CRS and ICANS.