Phase 1 Study of CD19-Specific Chimeric Antigen Receptor T Cells for Advanced B-Cell Non-Hodgkins Lymphoma, Acute Lymphocytic Leukemia, and Chronic Lymphocytic Leukemia

What this Trial Is About

Researchers are studying patients with certain blood cancers, including Non-Hodgkin Lymphoma, acute lymphocytic leukemia, and chronic lymphocytic leukemia, whose disease has returned or not responded to previous treatments. The study aims to test new immune therapies that combine antibodies and T cells to better fight these cancers. This research focuses on specially modified T cells that carry a receptor targeting CD19, a protein found on cancer cells, with added proteins to improve their effectiveness and persistence in the body. Participants will provide blood samples to create these modified T cells in the lab, where a virus is used to insert genes that produce the CD19 receptor along with stimulating proteins CD28, with or without CD137. Patients will receive infusions of these T cells at different doses, and some may receive chemotherapy beforehand to reduce their existing T cells and improve treatment effectiveness. If initial treatment shows benefit after six weeks, additional infusions may be offered at regular intervals. During the study, patients will be closely monitored for side effects, how long the modified T cells last, and any signs of cancer response. Follow-up includes blood tests and clinical exams, with long-term monitoring for up to 15 years to detect any lasting effects of the gene therapy. The main goal is to find the highest safe dose and understand the treatments impact on the cancer and patient safety.

Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)