eligibility_summary
Inclusion: adults with CD20+ aggressive B‑NHL progressing after ≥2 systemic lines incl anti‑CD20 and alkylator, measurable disease, ECOG 0–1, adequate marrow/renal/hepatic function, tumor tissue available, during expansion, biopsy if safely accessible. Exclusion: prior allo‑SCT/solid organ transplant or anti‑CD20×CD3 bsAb, MCL, CNS lymphoma, recent therapy/radiation, high‑dose steroids, comorbidities/infections per protocol, hypersensitivity to allopurinol and rasburicase.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1, single-arm study in adults with relapsed/refractory aggressive B‑cell NHL testing IV step‑up dosing of two bispecific monoclonal antibodies: 1) REGN5837, an anti‑CD22 x anti‑CD28 costimulatory bispecific mAb that binds CD22 on B cells and CD28 on T cells to deliver CD28 costimulation (does not activate T cells without TCR signal). Type: costimulatory T‑cell–engager. 2) Odronextamab (REGN1979), an anti‑CD20 x anti‑CD3 T‑cell–redirecting bispecific mAb that brings CD3+ T cells to CD20+ B cells to induce cytotoxicity. Targets/cells/pathways: malignant B cells (CD20, CD22) and T cells (CD3, CD28), leverages TCR activation (CD3) plus CD28 costimulation to enhance immune synapse formation and T‑cell–mediated killing of B‑NHL. Primary aim: safety/tolerability and RP2D, also PK, immunogenicity, and preliminary efficacy.