eligibility_summary
Include: adults with untreated FL grade 1-3a, stage II-IV, ECOG<=2, high tumor burden per GELF, measurable disease, adequate organ function, consent and strict contraception. Exclude: CNS lymphoma, recent malignancy, serious infection or immunodeficiency, strong CYP3A inhibitors, major cardiac (QTc>=470), bleeding/stroke, recent live vaccine/surgery/other trials, pregnancy, life expectancy<6 mo, neuropathy>1, CD20 mAb/IMiD exposure, GI malabsorption, autoimmune/pneumonitis, SJS/TEN/DRESS.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 2 single-arm trial in untreated high–tumor-burden follicular lymphoma testing: 1) Obinutuzumab (GA101/Gazyva): a type II, glycoengineered anti‑CD20 monoclonal antibody (IV). Mechanism: binds CD20 on B cells, causing potent B‑cell depletion via enhanced antibody‑dependent cellular cytotoxicity (ADCC), direct cell death, and some complement activity. 2) CC‑99282: an oral CELMoD (cereblon E3 ligase modulator) small molecule. Mechanism: binds cereblon to induce proteasomal degradation of IKZF1/IKZF3, leading to T‑ and NK‑cell activation (↑IL‑2, cytotoxicity) and direct antitumor effects in B‑cell malignancies via IRF4/MYC suppression. Target cells/pathways: CD20+ malignant B cells, FcγR‑mediated NK‑cell ADCC, T‑cell activation, cereblon–CRL4 pathway with IKZF1/3 degradation and downstream IRF4/MYC signaling in FL. Combination aims to couple direct B‑cell killing with heightened immune effector function.