eligibility_summary
Inclusion: adults (≥18) with MCL eligible for Tecartus, ECOG 0–2, recovery to ≤G1, protocol washouts, contraception, adequate labs/organ function incl LVEF ≥40 and CrCl ≥30. Exclude: pirtobrutinib >2m or intolerant/progressive, prior CAR‑T, major cardiac/QTc>470, active HIV, HBV/HCV viremia, CMV, CNS MCL, chronic steroids, unresolved >G1 AEs, pregnancy/lactation, malabsorption, bleeding risk/warfarin, recent surgery/SCT, stroke/ICH, autoimmune cytopenia.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, open-label, randomized trial in relapsed/refractory mantle cell lymphoma testing: 1) Pirtobrutinib (Jaypirca) — oral, reversible, non‑covalent Bruton’s tyrosine kinase (BTK) inhibitor (small-molecule) with preserved activity against BTK resistance mutations, used as bridging (days −27 to −7) and either continued concurrently for 1 year post–CAR T (Arm A) or stopped before CAR T with no concurrent use (Arm B). 2) Brexucabtagene autoleucel (Tecartus) — autologous CD19‑directed CAR T‑cell therapy (gene/cell therapy) that redirects patient T cells to kill CD19+ B cells. Targets/pathways: BTK in the B‑cell receptor signaling pathway to block malignant B‑cell survival/proliferation, CD19 on malignant B cells for CAR T–mediated T‑cell activation and cytotoxic elimination of CD19+ MCL.