Safety and Feasibility of CD19 CAR T Cells Using CliniMACS Prodigy for Relapsed/Refractory CD19 Positive ALL and NHL

This pilot study examines the safety and efficacy of anti-CD19 CAR T cells manufactured on-site in children and young adults with relapsed or refractory CD19+ B cell acute lymphoblastic leukemia or CD19+ B cell non Hodgkin lymphoma. Patients will undergo screening, leukapheresis (cell collection), lymphodepleting chemotherapy with fludarabine and cyclophosphamide, followed by the anti-CD19 CAR T cell infusion. The lymphodepleting chemotherapy is administered over four days IV to prepare the body for the CAR T cells. The anti-CD19 CAR-T cells are infused between 2-14 days after the last dose of chemotherapy. This study is designed for participants to begin lymphodepleting chemotherapy during the CAR T cell manufacture and receive a fresh cell infusion on the day that manufacturing is complete. Some patients may need more time in between the cell collection and the CAR T cell infusion, therefore, the cells may be manufactured and frozen prior to administration. Patients will be followed for a year after the cell infusion on the study and for up to 15 years to monitor for potential long term side effects of cell therapy.

NCT Number	NCT05779930
Lead Sponsor	Nationwide Children's Hospital
Conditions	Acute Lymphoblastic Leukemia, in Relapse, Non-Hodgkin's Lymphoma, Relapsed, Non-Hodgkin's Lymphoma Refractory, Acute Lymphoblastic Leukemia With Failed Remission, B-cell Non Hodgkin Lymphoma, B Cell Leukemia
Enrollment	12 participants
Start Date	2025-10
Primary Completion	2030-12 (estimated)
Study Completion	2035-12 (estimated)
Updated on ClinicalTrials.gov	2025-08-15