New Cell Therapy Using CD7-Specific CAR T Cells for High-Risk T-Cell Leukemia and Lymphoma

What this Trial Is About

This research focuses on patients with T-cell leukemia or lymphoma, which are types of blood and lymph gland cancers. It explores a novel treatment approach combining antibodies and T cells to fight the disease. The study specifically investigates CD7 chimeric receptor T cells with an added protein called CD28, aiming to improve the ability of these cells to target and kill cancer cells. These investigational cells are not yet approved by the Food and Drug Administration. The treatment involves using T cells collected from the patients previous bone marrow transplant donor. These T cells are genetically modified in the lab using a retrovirus to attach the CD7 antibody and CD28 protein, then grown and frozen for infusion. Patients receive chemotherapy with cyclophosphamide and fludarabine for three days before the T cell infusion to reduce their own T cells and make room for the new cells. The modified T cells are then given through an intravenous injection, with four dose levels being evaluated. Participants undergo various medical tests before, during, and after treatment, including physical exams, blood tests, tumor scans, and heart ultrasounds. Blood samples will be collected regularly for up to 15 years to study how long the modified T cells last and their effects. After infusion, patients remain near the clinic for at least four weeks for monitoring, with possible hospitalization if side effects occur. The primary outcome measured is the rate of dose-limiting toxicity within four weeks, along with overall response rate.

Novel Unedited Allo Cell Therapy For High Risk T-Cell Malignancies Using CD7-Specific Car T Cells