Clinical Trial

Disease: Relapsed or Refractory B cell Malignancies, (NCT04227015)

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include a type of non-Hodgkin lymphoma (NHL) called B-cell lymphoma, and B-cell acute lymphoblastic leukaemia (B-ALL). 

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterised by abnormalities of the "B cells" (a type of white blood cell that makes antibodies to help fight infection). The condition may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Non-Hodgkin lymphoma (also known as non-Hodgkin’s lymphoma, NHL, or sometimes just lymphoma) is a cancer that starts in white blood cells called lymphocytes, which are part of the body’s immune system. NHL is a term that's used for many different types of lymphoma that all share some of the same characteristics. NHL usually starts in lymph nodes or other lymph tissue, but it can sometimes affect the skin. Non-Hodgkin lymphoma is one of the most common cancers in the United States, accounting for about 4% of all cancers. 

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. 

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.

HL accounts for about 4% of all cancers in the U.S. The American Cancer Society estimates 80,550 people will be diagnosed with NHL in 2023. ALL accounts for less than 1% of all cancers in the U.S., with around 6,540 new cases estimated in 2023.
Official title:
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy


Name: He Huang, MD   

Phone: 86-13605714822    



Name: Jimin Shi, MD   

Phone: 86-13857119907    



China, Zhejiang

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Study start:
Jan. 8, 2020
72 participants
Gene editing method:
Type of edit:
Gene knock-out
T Cell Receptor Alpha Constant TRAC, CD52 molecule
Delivery method:
Lentiviral transduction - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


The aim of the study is to explore the dose-related safety of the cell therapy. CTA101 is a CRISPR-Cas9 engineered, off-the-shelf, CD19/CD22 dual-targeted CAR T cell product. Study participants will receive two infusions of Universal CD19-directed CAR-T cells in escalating doses.

Last updated: Apr. 20, 2024
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