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

Disease info:

B-cell lymphoma refers to types of non-Hodgkin lymphoma that are characterized 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 Leukemia is an aggressive (fast-growing) type of leukemia (blood cancer) 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 leukemia (ALL). Also called B-cell acute lymphocytic leukemia and precursor B-lymphoblastic leukemia. 

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:
A Study of CTA101 UCAR-T Cell Injection in Patients With Relapsed or Refractory CD19+ B-line Hematological Malignancy
Who:

He Huang, Clinical Professor, Zhejiang University

Locations:

China, Zhejiang

Study start:
Jan. 8, 2020
Enrollment:
72 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
T Cell Receptor Alpha Constant TRAC, CD19/CD22 molecule
Delivery method:
T Cell Receptor Alpha Constant TRAC, CD19/CD22 molecule - Ex-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

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. 27, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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