Phase 1 Study of Engineered T-Cells with CD5 Chimeric Antigen Receptor for Treating T-Cell Leukemia and Lymphoma

What this Trial Is About

This trial studies patients with T-cell leukemia or lymphoma, types of blood cancers. Researchers are evaluating a new treatment that combines antibodies and T cells to fight these cancers. The study focuses on attaching a modified antibody called anti-CD5, combined with a protein called CD28, to T cells to help them better target and kill cancer cells. This approach uses either the patients own T cells or those from a previous bone marrow transplant donor, depending on availability and suitability. The treatment involves collecting T cells from the patient or donor and modifying them in the lab using a special virus to insert the CD5 chimeric receptor with CD28. Before receiving the modified T cells, patients get chemotherapy with cyclophosphamide and fludarabine to help the new T cells work better. They also receive a drug called Rituximab to reduce risks of viral infections. The modified T cells are given by IV infusion, and patients remain under close monitoring for side effects and viral infections. Participants undergo medical tests before, during, and after treatment, including blood tests, physical exams, tumor measurements, and virus monitoring. Blood samples will be taken over 15 years to study how long the modified T cells last and to check for long-term effects. Patients are followed closely for 6 to 8 weeks after infusion, with visits at least twice a week initially. The study also evaluates safety and response to treatment, and some patients may receive additional infusions if they show benefit without safety concerns.

Autologous T-Cells Expressing a Second Generation CAR for Treatment of T-Cell Malignancies Expressing CD5 Antigen