eligibility_summary
Eligible: B‑cell NHL per 2014 Lugano, relapsed/refractory after anthracycline + anti‑CD20 first‑line, ECOG 0–2, adequate organs and veins for leukapheresis, informed consent, contraception, no prior CD19 CAR‑T. Exclude: prior allo‑HSCT, CNS disorders, other malignancy in 2 yrs (except CIS, NMSC, superficial bladder), serious CV disease/LVEF<50%, hypersensitivity, active HBV/HCV, HIV or infection, active autoimmune/organ transplant/immunosuppression, uncontrolled systemic disease, substance abuse.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II single-arm study in relapsed/refractory B-cell NHL integrating multiple therapies around anti-CD19 CAR-T. Interventions: (1) Bridging before CAR-T: BTK inhibitor (oral, 160 mg bid) + radiotherapy ± chemotherapy for tumor debulking, (2) Post-CAR-T maintenance: BTKi for all, add PD-1 inhibitor (200 mg IV q3w, up to 2 years) for partial responders. Mechanisms: CAR-T (autologous gene-modified T cells) targets CD19 on B cells to induce cytotoxic killing. BTKi (small-molecule Bruton’s tyrosine kinase inhibitor) blocks B-cell receptor (BCR) signaling, reducing malignant B-cell survival and potentially improving CAR-T expansion/persistence. PD-1 inhibitor (monoclonal antibody checkpoint blocker) prevents PD-1/PD-L1–mediated T-cell exhaustion to sustain CAR-T activity. Targets/pathways: CD19, BTK/BCR pathway, PD-1/PD-L1 axis, RT/chemo for cytoreduction and immunogenic cell death.