eligibility_summary
Adults ≥18 with relapsed/refractory CD19+ aggressive B‑NHL, measurable disease, life ≥3 mo, no CNS lymphoma, adequate labs, LVEF ≥55%, ECOG 0–1, apheresis‑fit, prior toxicities ≤G1. Exclude: pregnancy, prior allo cell tx/CAR‑T/anti‑CD19 (except BRL‑201 reinfusion), Richter’s, active infection (HBV DNA+, HCV RNA+, HIV, syphilis), autoimmune/immunodef/other malignancy, major CV disease, recent VTE or anticoagulation, non‑central tubes, urgent tumor issues, severe drug allergy, live vaccines ≤6 wks, investigator judgment.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT05741359 tests BRL-201, an autologous, gene-edited CAR‑T cell therapy (cellular immunotherapy) for relapsed/refractory B‑cell non‑Hodgkin lymphoma. Intervention: CD19‑targeted CAR‑T cells manufactured via non‑viral, site-specific integration at the PDCD1 (PD‑1) locus. Mechanism of action: the CAR enables T‑cell recognition and killing of CD19+ malignant B cells, integration at the PD‑1 locus disrupts PD‑1 checkpoint signaling to reduce exhaustion and enhance antitumor activity, while enabling controlled CAR expression without viral vectors. Targets: CD19 antigen on B lymphocytes and the PD‑1/PD‑L1 inhibitory pathway within infused T cells. Design: single‑arm phase I/II, 3+3 dose escalation (5–10×10^6 CD3+CAR+ cells/kg) to define RP2D.