Study of Polatuzumab Vedotin, Obinutuzumab, and Glofitamab Around CAR-T Cell Therapy for Large B-cell Lymphoma

What this Trial Is About

Researchers are evaluating a new combination of cancer drugs—glofitamab, polatuzumab vedotin, and obinutuzumab—in patients with large B-cell lymphoma (LBCL) that has returned or not responded to previous treatments. The study aims to determine the safety and effectiveness of this drug combination before and after CAR-T cell therapy. It is a phase 2, open-label trial conducted in two parts focusing on different patient groups based on their response to prior treatments and CAR-T therapy. In Part 1, patients receive two cycles of the drug combination called Pola-Glofit as a bridging treatment before planned CAR-T therapy. Obinutuzumab is given one week before the first dose of glofitamab. After two cycles, patients have a PET-CT scan to assess response. Those suitable proceed to CAR-T therapy, while others may receive additional cycles of Pola-Glofit and then glofitamab alone. In Part 2, patients receive six cycles of Pola-Glofit followed by six cycles of glofitamab. All treatment cycles last 21 days, with a step-up dosing schedule for the drugs, including hospital stays for glofitamab infusions during the first cycle. Participants undergo regular assessments including scans to measure tumor response and safety monitoring throughout treatment and follow-up. The main outcomes measured are the overall response rate to the bridging treatment before CAR-T therapy and progression-free survival up to four years after treatment. Participants are followed until one year after completing treatment to monitor long-term effects and disease status.

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