CD19-CAR_Lenti T Cells in Pediatric Patients Affected by Relapsed/Refractory CD19+ ALL and DLBCL or PML

This study aims at evaluating the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B-cell surface antigen CD19, following administration of lymphodepleting chemotherapy regimen, in children and adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B- ALL) or aggressive B-cell Non-Hodgkin lymphoma (B-NHL). The phase II extension is aimed at testing the efficacy of the treatment at the optimal dose defined in the phase I. In addition, the investigators hypothesize that it is feasible to successfully manufacture CAR T cells to meet the established release criteria at a maximum target dose of 3.0 x 10\^6 cells/kilogram recipient total body weight in this patient population using the Miltenyi CliniMACS Prodigy® closed transduction system.

NCT Number	NCT04787263
Lead Sponsor	Bambino Gesù Hospital and Research Institute
Conditions	Acute Lymphoblastic Leukemia, Diffuse Large B Cell Lymphoma, Primary Mediastinal Lymphoma
Enrollment	32 participants
Start Date	2021-03-04
Primary Completion	2027-03 (estimated)
Study Completion	2038-03-03 (estimated)
Updated on ClinicalTrials.gov	2025-12-02