Clinical Trial

Disease: Relapsed/​Refractory Hematologic Malignancies (NCT06492304)

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 Phase 1/2 Dose Evaluation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD70 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX131) in Adult Subjects With Relapsed/Refractory Hematologic Malignancies
Who:
Partners:
Locations:

Arizona, United States

Research Site 6, Phoenix, Arizona, United States, 85054

California, United States

Research Site 2, Stanford, California, United States, 94305

Massachusetts, United States

Research Site 3, Boston, Massachusetts, United States, 02114

New York, United States

Research Site 5, Bronx, New York, United States, 10467

Research Site 4, New York, New York, United States, 10065

Texas, United States

Research Site 1, Houston, Texas, United States, 77030

Study start:
Aug. 13, 2024
Enrollment:
290 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene disruption, gene insertion
Gene:
TRAC, B2M, CD70, TGFBR2, and Regnase-1 disruption CD70-directed CAR construct insertion
Delivery method:
- Ex-vivo
IndicatorIndicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

The study may enroll up to 290 subjects in total. CTX131 is a CD70-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsed/refractory hematological malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease)

Last updated: Dec. 15, 2024
close
Search CRISPR Medicine