Disease: Relapsed Or Refractory CD19+ Leukemia and Lymphoma

Disease info:

Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that is used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissues, but it can sometimes affect the skin. 

B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive type of leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. It is the most common type of acute lymphoblastic leukaemia (ALL). B-ALL is also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

 

Frequency:
The American Cancer Society’s estimates for acute lymphocytic leukaemia (ALL) in the United States for 2020 are: About 6,150 new cases of ALL (3,470 in males and 2,680 in females) About 1,520 deaths from ALL (860 in males and 660 in females)
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
Who:

University of Pennsylvania, 

Sponsor:

University of Pennsylvania

Partners:

None 

Locations:

Not yet disclosed. 

Study start:
Jan. 1, 2022
Enrollment:
36
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
Beta-2 microglobulin (B2M), Class II Major Histocompatibility Complex Transactivator (CIITA) and TCR-α chain (TRAC)
Delivery method:
Electroporation - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

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.

Last updated: Oct. 6, 2021
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