Study of a New CAR-T Therapy with IL-15 for Treating Malignant Blood Cancers

What this Trial Is About

Researchers are studying a new CAR-T therapy that includes IL-15 expression to treat malignant blood cancers such as acute lymphocytic leukemia, non-Hodgkin lymphoma, and relapsed or refractory multiple myeloma. The main goal is to assess the safety and effectiveness of this treatment. Additionally, the study aims to understand how long the CAR-T cells survive in the body and how they activate and multiply. Participants will receive CAR-T cells infused intravenously at doses tailored to their specific blood cancer type, ranging from 0.5 to 5 million CAR-positive T cells per kilogram of body weight. The infusion is given using a blood transfusion device with a filter and saline rinsing. This single-arm, open-label study plans to enroll 45 patients and will monitor responses and survival following treatment. During the study, researchers will monitor the CAR-T cells survival in the body for six months and assess antitumor effects within 28 days after infusion. They will also track longer-term outcomes such as disease-free survival and overall survival over three years. Participants will undergo regular clinical visits, laboratory tests, and evaluations to measure treatment impact and safety throughout the study period.

A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors