eligibility_summary
Eligible: adults ≥18 with CNS-involved relapsed/refractory LBCL after ≥1 line, in CR/PR and stable post-salvage, ECOG 0–2, life expectancy ≥12 wks, contraception, adequate labs: ANC ≥1.0×10^9/L, Hgb ≥8 g/dL, Plt ≥50×10^9/L, bilirubin ≤1.5×ULN, ALT/AST ≤2.5×ULN (≤5×ULN if hepatic), CrCl ≥40 mL/min, lipase ≤1.5×ULN. Exclude: severe CNS symptoms, prior anti‑CD19 CAR, HIV+, live vaccine ≤30 d, autoimmune disease needing systemic therapy ≤12 mo, severe drug allergy, arrhythmia risk, stroke/ICH ≤3 mo, other malignancy now/≤3 y, investigator judgment, pregnant/lactating.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Interventions: Relmacabtagene autoleucel (Relma‑cel) followed by tislelizumab, BTK inhibitors may be added as needed. Drug types and mechanisms: • Relma‑cel is an autologous CD19‑directed CAR‑T cell therapy (genetically modified T cells with CAR containing CD3ζ and a costimulatory domain). It redirects patient T cells to recognize and kill CD19+ malignant B cells, producing systemic and CNS B‑cell depletion. • Tislelizumab is an anti–PD‑1 IgG4 monoclonal antibody engineered to minimize FcγR binding, it blocks PD‑1/PD‑L1 signaling to reinvigorate CAR‑T and endogenous T‑cell activity and reduce exhaustion. • BTK inhibitors are small‑molecule kinase inhibitors that block Bruton’s tyrosine kinase, suppressing B‑cell receptor signaling and survival of malignant B cells. Cells/pathways targeted: CD19+ B cells, PD‑1 checkpoint on T cells, BTK‑mediated BCR signaling in B cells.