Ignite Creation Date:
2024-05-06 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05037669
Status:
WITHDRAWN
Last Update Posted:
2023-06-22
First Post:
2021-08-24
Brief Title:
Programmed Allogeneic CRISPR-edited T Cells Engineered to Express Anti-CD19 Chimeric Antigen Receptor PACE CART19 in Patients With Relapsed Or Refractory CD19 Leukemia and Lymphoma
Sponsor:
University of Pennsylvania
Organization:
University of Pennsylvania
Study Overview
Official Title:
Phase I Trial of Programmed Allogeneic CRISPR-edited T Cells PACE Gene Edited to Eliminate Endogenous TCR HLA-class I and HLA-class II and Engineered to Express Anti-CD19 Chimeric Antigen Receptor PACE CART19 in Patients With Relapsed Or Refractory CD19 Leukemia and Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No available investigational product
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase I trial to assess the safety and feasibility of administering pre-manufactured allogeneic T cells from healthy donors expressing CD19-targeting chimeric antigen receptors lacking expression of HLA class I HLA class II molecules and endogenous TCR through CRISPR-mediated genome-editing of beta-2 microglobulin CIITA and T cell receptor alpha chain respectively These cells are called PACE CART19 cells
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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