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.
Disease: T-cell Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; T-non-Hodgkin Lymphoma, ALL, (NCT03690011)
Disease info:
Frequency:
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)
Who:
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, MD713-441-1450LaQuisa.Hill@bcm.edu
Contact: Martha Arredondo832-824-1201Martha.Arredondo@bcm.edu
Sponsor:
Partners:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Locations:
United States, Texas
Houston Methodist Hospital: Recruiting
Houston, Texas, United States, 77030
Contact: LaQuisa HIll, MD 832-824-4670 LaQuisa.Hill@bcm.edu
Texas Children's Hospital: Recruiting
Houston, Texas, United States, 77030
Contact: Rayne Rouce, MD 832-824-4716 rhrouce@txch.org
Study start:
Sep. 1, 2021
Enrollment:
21 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene knock-out
Gene:
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
Description
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