eligibility_summary
Eligible: adults 18–80 with pathologic MCL and measurable disease, no prior systemic therapy, ECOG 0–2, adequate organs (ANC ≥1×10^9/L, PLT ≥75×10^9/L, TBIL/ALT/AST ≤2×ULN, CrCl ≥30 mL/min, LVEF ≥50%), contraception as needed. Exclude: CNS disease, NYHA III/IV CHF, other cancers <3y, prior investigational drugs, active infection ≤2w, recent immunosuppression (except low-dose/inhaled), severe mAb/infusion/drug allergy, HBV/HCV/HIV/AIDS, pregnancy/lactation, or unsuitable.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2, single-arm first-line MCL study of: Obinutuzumab (type II anti‑CD20 monoclonal antibody) depleting CD20+ B cells via antibody-dependent cellular cytotoxicity, complement-mediated lysis, and direct cell death, Zanubrutinib (small‑molecule BTK inhibitor) blocking B‑cell receptor signaling (BTK→NF‑κB), Lenalidomide (IMiD) binding cereblon to degrade Ikaros/Aiolos, reducing IRF4/MYC signaling and boosting T/NK cell immunity, Cytarabine (antimetabolite nucleoside analog) inhibiting DNA polymerase/DNA synthesis, plus CAR‑T for high‑risk patients (autologous T cells engineered to kill malignant B cells). Targets: malignant mantle‑cell B lymphocytes, CD20, BCR/BTK pathway, cereblon-dependent transcriptional programs, and DNA replication machinery.