Disease: B-cell Acute Lymphoblastic Leukemia, ALL, (NCT04154709)

Disease info:

B-cell Acute Lymphoblastic Leukemia is an aggressive (fast-growing) type of leukemia (blood cancer) 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 leukemia (ALL). Also called B-cell acute lymphocytic leukemia and precursor B-lymphoblastic leukemia. 

Frequency:
The American Cancer Society’s estimates for acute lymphocytic leukemia (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:
CTA101 UCAR-T Cell Injection for Treatment of Relapsed or Refractory CD19+ B-cell Acute Lymphoblastic Leukemia
Who:

Study Director: Jun Nian Zheng  President, Xuzhou Medical University

Study Chair: Kai Lin Xu Ph.d The Affiliated Hospital of Xuzhou Medical University

Locations:

China, Jiangsu

Study start:
Dec. 10, 2019
Enrollment:
15 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
T Cell Receptor Alpha Constant (TRAC), CD19/CD22 molecule
Delivery method:
Electroporation and Lentivirus (LV) - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This study aims to evaluate the safety and feasibility of CTA101 in treating patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia. CTA101 is a CRISPR-Cas9 engineered, off-the-shelf, CD19/CD22 dual-targeted CAR T cell product. Study participants will receive one infusion of Universal CD19-directed CAR-T cells in escalating doses.

Last updated: Jul. 11, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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