eligibility_summary
Adults (≥18) with r/r CD19+ B‑ALL or B‑NHL. ALL: blasts >5% (BM) or >1% (flow), Ph− or Ph+ intolerant/nonresponsive to ≥2 TKIs. NHL: no response/relapse after ≥2L, primary refractory, or relapse post auto‑HSCT. Need measurable disease, adequate organs (Tbili ≤51, ALT/AST ≤3×ULN, Cr ≤176.8 μmol/L), LVEF ≥50%, SpO2 ≥92%, no active lung infection, ECOG 0–2, survival ≥3 mo, consent. Exclude neuro/cardiac disease, pregnancy/lactation or no contraception, HIV/active HBV/HCV, poor T‑cell expansion, uncontrolled illness, prior CAR ≤6 mo.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CD19-BAFF Targeted CAR T-cells—an autologous, gene‑modified biological cell therapy infused IV (3+3 dose escalation, Early Phase 1, single arm). Mechanism of action: Patient T cells are engineered to express chimeric antigen receptors that bind CD19 and a BAFF‑based target, triggering antigen-dependent T‑cell activation, cytokine release, and cytotoxic killing of malignant B cells. Targets: B‑cell lineage tumor cells expressing CD19 and elements of the BAFF signaling pathway on B cells (BAFF pathway receptors), in relapsed/refractory B‑ALL and B‑cell NHL.