eligibility_summary
Adults (≥18) with RR‑DLBCL who achieved PR 1–3 months after CD19 CAR‑T (enroll ≤3 months post‑PR), ECOG 0–2, measurable disease, tissue available, negative SARS‑CoV‑2 test, adequate blood counts and organ/renal function, life expectancy ≥12 wks, contraception. Exclude: CAR‑T nonresponders, prior bispecifics, CNS lymphoma/disease, neuropathy >G1, major CVD, uncontrolled comorbidities, active infection (HBV/HCV, controlled HIV allowed), other recent cancer/surgery, immunosuppression, pregnancy/breastfeeding, live vaccines, COVID‑19 within 30 d, chronic active EBV, prior solid organ/allo SCT, PML, HLH.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase II, single-arm study in RR-DLBCL patients with residual disease after CD19 CAR T (partial response at 1–3 months). Intervention: Glofitamab (Columvi), a CD20×CD3 bispecific monoclonal antibody (T‑cell engager). Mechanism: bivalent binding to CD20 on B cells and monovalent binding to CD3 on T cells to form an immune synapse, activate TCR/CD3 signaling, and drive T‑cell cytotoxicity (granzyme/perforin) against CD20+ lymphoma, independent of CD19. Goal is to reduce progression by overcoming CD19 antigen loss and mitigating T‑cell exhaustion, enhancing effector function in the tumor microenvironment. Regimen: obinutuzumab 1000 mg day 1 (type II anti‑CD20 mAb) as priming to deplete circulating B cells and lower CRS risk, glofitamab step‑up 2.5→10 mg in cycle 1, then 30 mg IV every 3 weeks for up to 12 cycles. Supportive prophylaxis: TMP‑SMX and acyclovir. Targets: CD20 on malignant B cells, CD3 on endogenous T cells, pathways—TCR activation, cytotoxic granule release.