Clinical Trial

Disease: T-cell Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; T-non-Hodgkin Lymphoma, ALL, (NCT03690011)

Disease info:

Acute lymphoblastic leukaemia (ALL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). Lymphoblastic lymphoma is an aggressive form of non-Hodgkin lymphoma. 
Lymphoblastic lymphoma usually develops from T-lymphocytes but occasionally develops from B-lymphocytes. 
Clinically, lymphoblastic lymphoma behaves very similarly to acute lymphoblastic leukaemia (ALL), and the two conditions are often treated in similarly.

The American Cancer Society’s estimates for acute lymphocytic leukemia (ALL) in the United States for 2020 (including both children and adults) are: About 6,150 new cases (3,470 in males and 2,680 in females).
Official title:
Cell Therapy for High Risk T-cell Malignancies Using CD7-Specific CAR Expressed on Non-Edited T Cells (CRIMSON-NE)

Principal Investigator: Rayne Rouce, MDPediatrics, Baylor College of Medicine
Principal Investigator: LaQuisa Hill, MDBaylor College of Medicine
Principal Investigator: Maksim Mamonkin, PhDBaylor College of Medicine

Contact: LaQuisa Hill,
Contact: Martha



The Methodist Hospital Research Institute

Center for Cell and Gene Therapy, Baylor College of Medicine


United States, Texas

Houston Methodist Hospital: Recruiting

Houston, Texas, United States, 77030

Contact: LaQuisa HIll, MD    832-824-4670   

Texas Children's Hospital: Recruiting

Houston, Texas, United States, 77030

Contact: Rayne Rouce, MD    832-824-4716   

Study start:
Sep. 1, 2021
21 participants
Gene editing method:
Type of edit:
Gene knock-out
Cluster of Differentiation 7 (CD7)
Delivery method:
Electroporation - Ex-vivo
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting


Patients eligible for this study have a type of blood cancer called T-cell leukemia or lymphoma (lymph gland cancer).

The body has different ways of fighting infection and disease. This study combines two different ways of fighting disease with antibodies and T cells. Antibodies are types of proteins that protect the body from bacterial and other diseases. T cells, or T lymphocytes, are special infection-fighting blood cells that can kill other cells including tumor cells. Both antibodies and T cells have been used to treat cancer; they have shown promise, but have not been strong enough to cure most patients.

T cells can kill tumor cells but there normally are not enough of them to kill all the tumor cells. Some researchers have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person.

The antibody used in this study is called anti-CD7. This antibody sticks to T-cell leukemia or lymphoma cells because of a substance on the outside of these cells called CD7. CD7 antibodies have been used to treat people with T-cell leukemia and lymphoma. For this study, anti-CD7 has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor.

In the laboratory, investigators have also found that T cells work better if they also add proteins that stimulate T cells, such as one called CD28. Adding the CD28 makes the cells grow better and last longer in the body, thus giving the cells a better chance of killing the leukemia or lymphoma cells. Finally, to make sure the T cells are able to grow and expand properly without accidentally targeting themselves (because they also have CD7 on their surface), investigators have removed the CD7 gene in the T cells using a genome editing technique called CRISPR-Cas9. Investigators have repeatedly shown in the laboratory and in our animal studies that removing the CD7 genes in T cells using CRISPR-Cas9 before adding the CAR to the cells helps them expand and kill better, and does not interfere with the other functions of the T cells.

In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells that have had CD7 removed from their surface. Investigators will then test how long the cells last. These CD7 chimeric receptor T cells with CD28 are investigational products not approved by the Food and Drug Administration.

Last updated: Jun. 5, 2023
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