Phase III Study of CD5 CAR-Engineered IL15-Transduced Cord Blood NK Cells with Lymphodepleting Chemotherapy for Relapsed or Refractory Blood Cancers

What this Trial Is About

Researchers are evaluating the safety, tolerability, and best dose of CAR 5IL15-transduced cord blood-derived natural killer CB-NK cells in patients with relapsed or refractory T-cell malignancies, mantle cell lymphoma, and chronic lymphocytic leukemia. The study aims to find the optimal dose and effectiveness for each specific disease. This trial includes patients who have these blood cancers expressing CD5 and have undergone previous treatments. Participants receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine given intravenously, followed by one of several doses of CAR.5IL15-transduced CB-NK cells also given intravenously. Phase 1 tests increasing doses to determine safety and optimal levels, and Phase 2 compares the two best doses identified. All patients receive the chemotherapy regimen before the cell infusion. During the study, participants are closely monitored for treatment-related side effects using established criteria over about a year. Researchers also assess the response to treatment, how long the infused NK cells persist, and immune system recovery. Participants provide informed consent and undergo regular evaluations including organ function tests and performance status assessments. The study may last several months to a year depending on individual response and follow-up.

Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances