Study of CAR T-cell Therapy with Adjusted Chemotherapy Doses for Patients With Moderate to Severe Kidney Problems

What this Trial Is About

Researchers are evaluating the feasibility of giving CAR T-cell therapy to patients who have moderate to severe kidney problems. This Phase 2 study focuses on adjusting the doses of chemotherapy drugs before CAR T-cell treatment to see if it can be safely administered in this patient group. The study targets patients with certain blood cancers including non-Hodgkin lymphoma, multiple myeloma, and adult acute lymphoblastic leukemia who have reduced kidney function. The study involves giving lymphodepleting chemotherapy drugs fludarabine and cyclophosphamide intravenously on Days -5 to -3 before CAR T-cell therapy. Patients with moderate kidney dysfunction will receive a 20% dose reduction of fludarabine, those with severe dysfunction a 40% reduction, and dialysis patients a 50% reduction of fludarabine along with a 25% reduction of cyclophosphamide. There is no dose reduction of cyclophosphamide for moderate and severe dysfunction groups. Participants will be monitored closely for side effects such as cytokine release syndrome, neurotoxicity ICANS, and low blood cell counts for 90 days after treatment. The study assesses safety outcomes and how well patients tolerate the adjusted chemotherapy doses before CAR T-cell infusion. The total study involvement timeline includes this 90-day safety evaluation period. Other medical evaluations will be conducted to ensure patient safety and treatment adherence under medical supervision.

CAR T-cell Therapy in Patients With Renal Dysfunction