Clinical Trial

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

Disease info:

B-cell malignancies are cancers that arise from abnormalities in B cells, and include B-cell lymphomas and leukaemias. While leukaemias typically originate in the bone marrow and spread through the bloodstream, lymphomas usually originate in the lymph nodes or the spleen and spread through the lymphatic system.

There are more than 70 known types of B-cell lymphoma, and these make up approximately 85 % of all cases of non-Hodgkin lymphomas in the United States. NHL is one of the most common cancers in the United States, accounting for about 4% of all cancers. B-cell lymphomas may grow and spread slowly with few symptoms (also known as indolent lymphoma) or may be very aggressive with severe symptoms. Other common types of B-cell lymphoma include:

  • Diffuse large B-cell lymphoma (DLBCL)
  • Follicular lymphoma
  • Chronic lymphocytic leukaemia (CLL) /small lymphocytic lymphoma (SLL)
  • Mantle cell lymphoma (MCL)
  • Marginal zone lymphomas
  • Burkitt lymphoma

In leukaemia, the bone marrow produces abnormal levels of white blood cells. B-cell acute lymphoblastic leukaemia (B-ALL) is an aggressive leukaemia in which too many B-cell lymphoblasts (immature white blood cells) are found in the bone marrow and blood. B-ALL is the most common type of ALL. Note that B-ALL is 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.

 

 

Frequency:
NHL 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 6,540 new cases estimated in the U.S. in 2023.
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 Investigators:

Yi Zhang, Professor., First Affliated Hospital of Zhengzhou University

He Huang, Professor, First Affliated Hospital of Zhejiang University

Sponsor:

Bioray Laboratories - Shanghai Bangyao Biotechnology Co., Ltd.

Partners:

The First Affiliated Hospital of Zhengzhou University

Second Xiangya Hospital of Central South University

First Affiliated Hospital of Zhejiang University

Locations:

China, Henan

First Affliated Hospital of Zhengzhou University, Zhengzhou, Henan, China, 450052

 

China, Zhejiang

First Affliated Hospital of Zhejiang University, Hangzhou, Zhejiang, China, 310003

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
Trial link:
https://clinicaltrials.gov/ct2/show/study/NCT03229876
Other links:

LinkB cell malignancies - Non-Hodgkin’s lymphoma informationLinkB-cell Acute Lymphoblastic Leukemia Disease InformationLinkNon-Hodgkin’s lymphoma frequencyLinkB-cell Acute Lymphoblastic Leukemia FrequencyLinkApplications and explorations of CRISPR-Cas9 in CAR T-cell therapyLinkThe Role of Gene Editing Within CAR T-Cell Therapy Development - Interview with Professor Waseem QasimLinkClinical Trial Update: Gene-edited CAR T Therapies

IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Suspended

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: Oct. 16, 2023
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