Clinical Trial

Disease: B-cell Acute Lymphoblastic Leukaemia, B-ALL, (NCT03232619)

Disease info:

Leukaemia is cancer of the white blood cells which are responsible for fighting infection. In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive (fast-growing) 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 ALL. Also called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

 

 

Frequency:
ALL accounts for less than 1% of all cancers in the U.S., with around 6,540 new cases estimated in the U.S. in 2023. ALL is the most common type of cancer found in children, though it can affect adults too.
Official title:
Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
Who:

Name: 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

Shanghai Bioray Inc., Shanghai, Shanghai, China, 200240

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. 20, 2024
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