GLORY: Glofit-GemOx With Liso-Cel For Lymphoma

This is a multi-center, phase II single-arm study to assess the efficacy and safety of glofitamab/gemcitabine/oxaliplatin (Glofit-GemOx) as bridging therapy followed by lisocabtagene maraleucel (liso-cel) in patients with relapsed/refractory large B-cell lymphomas. Participants will also receive obinutuzumab pre-treatment and undergo apheresis. The U.S. Food and Drug Administration (FDA) has approved obinutuzumab as a treatment option for relapsed/refractory large B-cell lymphomas. Obinutuzumab is a targeted cancer drug called a monoclonal antibody. Obinutuzumab works by attaching to a specific marker on certain white blood cells (including cancerous ones), flagging them so the body's immune system knows which cells to destroy. The U.S. Food and Drug Administration (FDA) has approved glofitamab as a treatment option for relapsed/refractory large B-cell lymphomas. Glofitamab is a T-cell-bispecific antibody that works by bringing the body's immune cells directly to cancer cells. Specifically, glofitamab attaches to cancerous B cells on one side and to T cells (the immune system's "killer" cells) on the other side, helping the T cells recognize and attack the cancer. This process activates the immune system so it can amplify its response and destroy tumor cells. Gemcitabine/oxaliplatin (GemOx) is a standard, widely used chemotherapy treatment for diffuse large B-cell lymphoma that has returned or gotten worse. Gemcitabine is a nucleoside analog chemotherapy agent that stops cancer cells from making new DNA. Cells need DNA to grow and divide so, by blocking this process, gemcitabine slows down or kills the cancer cells. Oxaliplatin is a platinum-based chemotherapy drug that damages the DNA inside cancer cells, preventing them from growing and dividing. This damage causes the cancer cells to stop working properly and, eventually, die. The U.S. Food and Drug Administration (FDA) has approved lisocabtagene maraleucel (liso-cel) as a treatment option for relapsed/refractory large B-cell lymphomas. Lisocabtagene maraleucel is a CAR-T cell therapy made from an individual's own immune (T) cells. A patient's T cells are extracted though a process called leukapheresis and engineered into CAR-T cells that recognize and attack cancer cells. These CAR-T cells are then returned into the body so they can find and kill the cancer. The resulting re-engineered cell product is called lisocabtagene maraleucel. The U.S. Food and Drug Administration (FDA) has not approved glofitamab with gemcitabine and oxaliplatin (Glofit-GemOx) as a treatment for any disease, but has been incorporated into the National Cancer Center Network (NCCN) guidelines as a recommended treatment in the United States for diffuse large B-cell lymphoma that has returned or gotten worse. Participants will receive treatment until completion or until their disease progresses, they experience another disease or illness that prevents further administration of study treatment, they experience unacceptable side effects, they demonstrate an inability or unwillingness to receive the medication regimen, or they withdraw from the study. Participants will be followed for up to 24 months after the last participant is enrolled. It is expected that about 52 people will take part in this research study. Bristol Myers Squibb Company is supporting this research study by providing funding for the clinical trial activities.