Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04787263
Status:
RECRUITING
Last Update Posted:
2021-03-26
First Post:
2021-03-02
Brief Title:
CD19-CAR_Lenti T Cells in Pediatric Patients Affected by RelapsedRefractory CD19 ALL and DLBCL or PML
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Bambino Gesù Hospital and Research Institute
Study Overview
Official Title:
Phase III Study of Anti-CD19 Chimeric Antigen Receptor-Expressing T Cells in Pediatric Patients Affected by RelapsedRefractory CD19 Acute Lymphoblastic Leukemia and Diffuse Large B Cell Lymphoma DLBCL or Primary Mediastinal B Cell Lymphoma PML
Status:
RECRUITING
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 relapsedrefractory 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 30 x 106 cellskilogram recipient total body weight in this patient population using the Miltenyi CliniMACS Prodigy closed transduction system
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None