Disease: T-Cell Chronic Lymphoblastic Leukaemia, CLL, (NCT04264078)

Disease info:

Leukaemia is cancer of the white blood cells. White blood cells help your body fight infection. Your blood cells form in your bone marrow. In leukaemia, the bone marrow produces abnormal white blood cells. These cells crowd out the healthy blood cells, making it hard for blood to do its work.

Leukaemia can develop quickly or slowly. Chronic leukaemia grows slowly. In acute leukaemia, the cells are very abnormal, and their number increases rapidly. Adults can get either type;

There are different types of leukaemia, including: 
Acute lymphocytic leukaemia
Acute myeloid leukaemia
Chronic lymphocytic leukaemia
Chronic myeloid leukaemia

Frequency:
Approximately 1.6 percent of men and women will be diagnosed with leukaemia at some point during their lifetime, based on 2014-2016 data. Prevalence of this cancer: In 2016, there were an estimated 414,773 people living with leukaemia in the US.
Official title:
Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial
Who:

Principal Investigator:Xi Zhang, MD    Xinqiao Hospital of Chongqing

Partners:

Gracell Biotechnologies (Shanghai) Co., Ltd

920th Hospital of Joint Logistics Support Force

The Second Affiliated Hospital of Chongqing Medical University

The Affiliated Hospital Of Guizhou Medical University

Central South University

The First Affiliated Hospital of Kunming Medical College

The General Hospital of Western Theater Command

Second Affiliated Hospital of Xi'an Jiaotong University

Nanfang Hospital of Southern Medical University

Fujian Medical University Union Hospital

The First Affiliated Hospital of Anhui Medical University

Tang-Du Hospital

Locations:

China, Chongqing

Study start:
Apr. 1, 2021
Enrollment:
30 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
T Cell Receptor Alpha Constant (TRAC), CD7 molecule
Delivery method:
- 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

The primary outcome of the trial is to test the anti-tumour efficiency of anti-CD7 UCAR-T cells and the secondary outcome of the trial is the long-term efficiency of anti-CD7 UCAR-T cells. GC027 is a first-in-human, universal CAR-T therapy manufactured from T cells of human leukocyte antigen (HLA) unmatched healthy donors using TruUCAR™ technology.

To reduce the possibility of graft-versus-host disease GvHD from allogeneic T cells, CRISPR-Cas9 is used to disrupt the T cell receptor alpha constant (TRAC) locus to eliminate surface expression of the TCR complex of TruUCAR product candidates. Furthermore, to eliminate potential fratricide (self-killing of CAR T cells during the production process), CRISPR-Cas9 is employd to disrupt CD7, a pan T and NK marker on the CAR T cells.

All patients received a single infusion of TruUCAR™ GC027.

Last updated: Apr. 13, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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