eligibility_summary
Adults (≥18) with path-confirmed relapsed/refractory MCL, KPS≥70, measurable disease, prior systemic therapy incl ≥1 BTKi, if prior CD19 therapy, post-therapy biopsy must confirm CD19+. Washout from prior therapy, AEs≤grade1. Adequate counts/organ function (ANC≥1500, Plt≥90K, CrCl≥30, hepatic within protocol). Consent, procedures, thrombosis prophylaxis, REMS contraception/testing. Exclude active infections, uncontrolled HIV/HBV/HCV, pregnancy, CNS lymphoma, recent SCT, lenalidomide-refractory/recent use, hypersensitivity, live vaccine, other active cancer therapy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm trial in relapsed/refractory mantle cell lymphoma after BTK inhibitor exposure tested: 1) Tafasitamab: Fc‑engineered anti‑CD19 monoclonal antibody (mAb). Mechanism: binds CD19 on malignant B cells, inducing antibody‑dependent cellular cytotoxicity (ADCC) and phagocytosis (ADCP) → B‑cell depletion. 2) Lenalidomide: oral immunomodulatory drug (IMiD). Mechanism: binds cereblon E3 ligase → degradation of IKZF1/IKZF3 → decreased IRF4/MYC, immune stimulation (enhances NK/T cells) and anti‑angiogenic effects. Combined rationale: lenalidomide boosts NK‑cell function, potentiating tafasitamab‑mediated ADCC. Cells/pathways targeted: CD19+ mantle B cells, immune effectors (NK cells/macrophages), cereblon–IKZF1/3–IRF4 axis in tumor/immune cells. Dosing: tafasitamab IV + lenalidomide D1–21 q28d up to 12 cycles. Status: terminated for slow accrual.