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

To join this study, people generally need to have large B-cell lymphoma that has either come back or not responded to earlier treatments. They must also have at least one measurable cancer spot that doctors can track. For the early treatment part of the study (Part 1), patients should be suitable for CAR-T cell therapy and generally feel well enough to participate.

For the second part of the study (Part 2), patients would have already had CAR-T cell therapy, but their cancer either didn't go away completely or came back. In both parts, patients must have generally good health aside from their cancer, including their blood, liver, and kidney functions. They also need to be free of certain infections like Hepatitis B or C.

T.here are also reasons why someone might not be able to join. These include having certain active infections, significant nerve problems, severe heart conditions, another type of cancer, or certain autoimmune diseases. Patients who have had recent major organ transplants or stem cell transplants, or who are currently having other cancer treatments, would also not be able to take part.

If you join this study, your treatment schedule will depend on whether you are in Part 1 or Part 2. All treatments are given over cycles lasting 21 days each. The medicines (Polatuzumab, Glofitamab, and Obinutuzumab) are given into your vein, usually on specific days within each cycle. For the very first dose of Glofitamab, you might need to stay in the hospital for 24 hours so doctors can keep a close eye on you.

In Part 1, you'll receive two cycles of Polatuzumab and Glofitamab (with Obinutuzumab given before the first cycle). After this, you'll have a scan to see how the treatment is working. If you're still suitable for CAR-T therapy, you'll then move on to that. If not, you might receive more cycles of the study drugs. In Part 2, you'd receive more cycles of the study drugs directly. Regular scans and blood tests will be part of your treatment to check its effects. After your treatment finishes, doctors will continue to follow up on your health for at least one year.