Disease: Relapsed or Refractory B-cell Malignancies, (NCT03229876)

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 Safety and Efficacy Study of CD19-UCART (Allogeneic Engineered T-cells Expressing Anti-CD19 Chimeric Antigen Receptor) in Patients With Relapsed or Refractory B-cell Hematologic Malignancies
Who:

Principal Investigator: Yi Zhang, Professor.       First Affliated Hospital of Zhengzhou University

Partners:

The First Affiliated Hospital of Zhengzhou University

Second Xiangya Hospital of Central South University

Locations:

China, Henan

China, Hunan

Study start:
Jun. 1, 2019
Enrollment:
20 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
T Cell Receptor Alpha Constant (TRAC), Human Leukocyte Antigen (HLA-I)
Delivery method:
- 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 ascending doses of CD19-UCART in patients with relapsed or refractory B-cell hematological malignancies. In specific, th primary outcome will be to:

a. monitor the occurrence of study related adverse events that are "possibly", "likely", or "definitely" related to the study treatment any time from the first day of treatment until week 24.

b. monitor possbile epithelial damage of target organs including skin, liver, gastrointestinal tract within 14-42 days.

c. evaluate the duration of in vivo survival of CD19-CART cells also defined as "engraftment".

CD19-UCART is a kind of "off-the-shelf" product originated from health donor'saperipheral bloodmononuclear cell (PBMC). All patients will be treated with 1 injection of CD19-UCART and each CD19-UCART injection will be administered at Day 0. A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection.

Last updated: Apr. 5, 2021
Source: National Medical Product Administration (NMPA)
english.nmpa.gov.cn
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