Clinical Trial

Disease: Relapsed or Refractory B-cell Malignancies, (NCT04933825)

Disease info:

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.

B-cell acute lymphoblastic leukaemia 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 acute lymphoblastic leukaemia (ALL). ALL may also be called B-cell acute lymphocytic leukaemia and precursor B-lymphoblastic leukaemia. 

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 (NHL) is one of the most common cancers in the United States, accounting for about 4% of all cancers. About 77,240 people will be diagnosed with NHL. This includes both adults and children.

Frequency:
The American Cancer Society’s estimates for acute lymphocytic leukemia (ALL) in the United States for 2020 are: About 6,150 new cases and about 1,520 deaths from ALL.
Official title:
An Exploratory ,Open-label, and Single Center Study to Evaluate the Safety and Efficacy of ET-02 in Patients With Relapsed or Refractory B-cell Malignancies(NHL/ALL).
Who:

Ling Qin, Ph.D

Partners:

The First Affiliated Hospital of Henan University of Science and Technology

Locations:

Luoyang, Henan, China

Study start:
Jul. 20, 2021
Enrollment:
18
Gene editing method:
CRISPR-Cas9
Type of edit:
Undisclosed
Gene:
Undisclosed
Delivery method:
Undisclosed - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

The purpose of this study is to evaluate the safety and efficacy of CD19-UCART in patients with relapsed or refractory B-cell haematological malignancies. Four escalating dose-levels of ET-02 will be evaluated using a "3+3" design. A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.

Last updated: Jan. 4, 2022
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