Disease: Relapsed/Refractory Haematopoietic Malignancies (NCT04767308)

Disease info:

Haematological cancers most often begin in the bone marrow where blood is produced. Stem cells in the bone marrow develop into white blood cells, red blood cells, or platelets. Blood cancers occur when uncontrolled growth of abnormal blood cells overtakes the development of normal blood cells and interferes with the regular functions of these cells. Blood cancers fall into three categories: leukaemia, lymphoma, and myeloma.

Leukaemias are blood cell cancers; some leukaemias are fast growing, while others develop slowly. Lymphoma occurs when lymphocytes (infection-fighting white blood cells) develop abnormally and become cancerous. These multiply and aggregate in lymph nodes and other tissues. Among common lymphomas are Hodgkin lymphoma, non-Hodgkin Lymphoma, AIDS-related lymphoma, and primary central nervous system (CNS) lymphoma. Myeloma is a cancer that occurs in plasma cells. Normal plasma cells produce antibodies that fight disease and infection. However, when abnormal plasma cells develop, they interfere with  antibody production and lead to reduced immunity.

Frequency:
Between 2006 and 2016, the global leukaemia incidence increased by 26%—from 370,482 to 466,802 cases. Non-Hodgkin lymphoma increased by 45%, from 319,078 to 461,164 cases.
Official title:
A Single-center, Single-arm Exploratory Clinical Trial to Evaluate the Safety and Efficacy of Fully Human Anti-CD5 Chimeric Antigen Receptor T Cells (CT125A Cells) for the Treatment of Relapsed/Refractory CD5+ Hematopoietic Malignancies
Who:

 

Principal Investigator:Jianfeng Zhou, PhD, MD  Huazhong University of Science and Technology
 

Locations:
Study start:
Mar. 10, 2021
Enrollment:
18 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
CD5 molecule
Delivery method:
- Ex-vivo
Safety updates:

No information 

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

Status: Active not recruiting

Description

In the current study, the safety and efficacy of a novel CAR T cell therapy, termed CT125A cells, are evaluated in patients with relapsed/refractory CD5+ haematopoietic malignancies. The endogenous CD5 in CT125A cells is knocked out via CRISPR-Cas9 genome editing technology to prevent fratricide during CAR T cell manufacturing.

Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocyte depletion. After lymphodepletion, subjects will receive one dose of with CT125A cells by intravenous (IV) infusion.

Last updated: Apr. 5, 2021
Source: US National Institutes of Health (NIH)
clinicaltrials.gov
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