eligibility_summary
Include: Adults ≥18, ECOG 0–2, histologic R/R mantle cell lymphoma, CD20+ if previously anti‑CD20, tumor tissue available and genomic profiling ≤6 mo, ≥1 prior systemic line with BTKi failure, evaluable disease, adequate marrow/renal/hepatic function, contraception/consent, life expectancy ≥12 wks. Exclude: recent therapy/surgery/RT/CAR‑T, active HBV/HCV, uncontrolled HIV/infection, CNS disease, major comorbidity/allergy, recent SCT, recent/refractory lenalidomide, prior CD20×CD3, live vaccine, immunosuppression.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm trial testing a CD20xCD3 bispecific plus an IMiD in relapsed/refractory mantle cell lymphoma after BTK inhibitor failure. Interventions: 1) Glofitamab (IV), a T‑cell–engaging bispecific antibody (CD20×CD3, 2:1 format) that redirects patient T cells via CD3 to kill CD20+ malignant B cells. 2) Obinutuzumab (IV), a type II, glycoengineered anti‑CD20 monoclonal antibody used as lead‑in/debulking to reduce CRS risk, depletes B cells via enhanced ADCC/ADCP and direct cell death. 3) Lenalidomide (oral), an IMiD that binds cereblon (CRBN) E3 ligase to degrade IKZF1/3, boosting T‑ and NK‑cell activation, IL‑2 production, and anti‑tumor immunity, with anti‑angiogenic and direct tumor effects. Targets/pathways: CD20 on lymphoma B cells, CD3 on T cells, CRBN-IKZF1/3 pathway, FcγRIIIa‑mediated ADCC, T‑cell cytotoxic synapse formation and NK‑cell effector functions.