Phase 2 Study of Polatuzumab Vedotin, Obinutuzumab, and Glofitamab Before and After CAR-T Cell Therapy for Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating a new combination of cancer drugsglofitamab, polatuzumab vedotin, and obinutuzumabin patients with large B-cell lymphoma LBCL that has come back or not responded to previous treatments. This phase 2, open-label trial aims to determine how safe and effective this drug combination is before and after CAR-T cell therapy, a specialized treatment for this type of lymphoma. The trial has two parts. In Part 1, patients receive two cycles of the drug combination as bridging treatment before CAR-T therapy. Obinutuzumab is given one week before the first dose of glofitamab. After two cycles, a PET-CT scan checks the response. If responsive and suitable, patients proceed to planned CAR-T therapy if not, they may receive additional cycles of the drug combination and then glofitamab alone. In Part 2, patients who did not achieve complete metabolic response or progressed after CAR-T receive six cycles of the combination followed by six cycles of glofitamab. Each treatment cycle lasts 21 days, with specific dosing schedules and hospital stays for intravenous infusions. Participants will be closely monitored throughout treatment and followed up until one year after the last patients treatment ends. Assessments include PET-CT scans and safety monitoring. Researchers measure how well the lymphoma responds to treatment, progression-free survival, overall survival, and treatment safety. The study includes detailed evaluations before, during, and after CAR-T therapy to understand the effects of the drug combination on this lymphoma type.

A Trial of Polatuzumab Vedotin, Obinutuzumab and Glofitamab As a Peri-CAR-T Cell Treatment Strategy in Large B-cell Lymphoma