Clinical Trial

Disease: Refractory or recurrent B-cell Acute Lymphoblastic Leukemia, ALL, (NCT03232619)

Disease info:

B-cell acute lymphoblastic leukaemia 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 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 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:
Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
Who:

Principal Investigator: Yunxiao Xu, MD Second Xiangya Hospital of Central South University

Sponsor:

Bioray Laboratories - Bangyao Biotechnology Co., Ltd. 

Partners:

Second Xiangya Hospital of Central South University

Locations:

China, Shanghai

Study start:
Aug. 1, 2018
Enrollment:
4 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out and gene knock-in
Gene:
T Cell Receptor Constant (TRC), anti- CD19 CAR
Delivery method:
Non-viral - Ex-vivo
Trial link:
https://www.clinicaltrials.gov/ct2/show/record/NCT03232619
Other links:

LinkB-cell Acute Lymphoblastic Leukemia Disease Information.LinkB-cell Acute Lymphoblastic Leukemia FrequencyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem Qasim

IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

UCART is an allogeneic CAR-T cell therapy, in which CRISPR-Cas9 technology is used to disrupt the T cell receptor constant locus (TRAC) and the CD19 cell surface molecule in T cells from healthy donors. For this trial, two kinds of CD19-CART cells have been engineered. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanised scFv. This study aims to evaluate the safety and efficacy of both murine and humanised CD19-CART in treating refractory or recurrent B-cell acute lymphoblastic leukaemia (ALL).

Last updated: Apr. 10, 2022
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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