Clinical Trial

Disease: T-Cell Lymphoblastic Leukaemia and Lymphoma, (NCT04264078)

Disease info:

T-cell acute lymphoblastic leukaemia (T-ALL) is a type of acute leukaemia meaning that it is aggressive and progresses quickly. It affects the lymphoid-cell-producing stem cells, in paticular a type of white blood cell called T lymphocytes as opposed to acute lymphoblastic leukaemia (ALL) which commonly affects B lymphocytes. A lymphoid stem cell becomes a lymphoblast cell and then one of three types of lymphocytes (white blood cells):

  • B lymphocytes that make antibodies to help fight infection.
  • T lymphocytes that help B lymphocytes make the antibodies that help fight infection.
  • Natural killer cells that attack cancer cells and viruses.

There are no specific signs or symptoms which would allow a diagnosis of T-ALL to be made. The most common signs and symptoms are caused by the bone marrow being unable to produce enough normal blood cells. T-ALL often causes swolen lymph nodes in the middle part of the chest (mediastinum) which may affect breathing or the circulation. The results of a simple blood count will usually indicate leukaemia although, rarely, a blood count may be normal. Virtually all patients with T-ALL will have bone marrow samples taken to confirm the diagnosis and to help to determine exactly what type of leukaemia a patient has. 

The main ways in which leukaemia is treated are:

  • Chemotherapy – Cell-killing drugs. Steroids are normally used along with chemotherapy for T-ALL
  • Radiation therapy – Usually only given as part of a stem cell transplant in T-ALL
  • Stem cell transplant – Younger/fitter patients may be given a stem cell transplant (bone marrow transplant). This is done using healthy stem cells from a donor. This is also done for T-ALL if chemotherapy does not cure the disease. 

Relapsed refers to when a patient has received active treatment, went off treatment and then the disease came back, whereas refractory refers to disease that is progressing despite active treatment.

The American Cancer Society’s estimates approximately 6,540 new cases of Acute Lymphoblastic Leukaemia (ALL) in 2023, accounting for less than 1% of all cancers in the United States.
Official title:
Anti-CD7 Universal CAR-T Cells for CD7+ T/NK Cell Hematologic Malignancies: a Multi-center, Uncontrolled Trial



Name: Xi Zhang, MD

Phone: +8613808310064 ext +8613808310064


Name: Ruihao Huang

Phone: +8618984398751 ext +8618984398751



Gracell Biotechnologies (Shanghai) Co., Ltd

920th Hospital of Joint Logistics Support Force of People's Liberation Army of China

The Second Affiliated Hospital of Chongqing Medical University

The Affiliated Hospital Of Guizhou Medical University

Central South University

First Affiliated Hospital of Kunming Medical University

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


China, Chongqing

Department of Hematology, Xinqiao Hospital, ChongQing, Chongqing, China, 400037

Study start:
Mar. 1, 2021
30 participants
Gene editing method:
Type of edit:
Gene knock-out
T Cell Receptor Alpha Constant (TRAC), CD7 molecule
Delivery method:
- Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


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: Dec. 28, 2023
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