Disease: T-cell Acute Lymphoblastic Leukemia; T-cell Acute Lymphoblastic Lymphoma; T-non-Hodgkin Lymphoma

Disease info:

Acute lymphoblastic leukemia (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.

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 Autologous T Cells (CRIMSON)
Who:

Principal Investigator: Rayne Rouce, MD Pediatrics, Baylor College of Medicine
Principal Investigator: La Quisa Hill, MD Baylor College of Medicine
Principal Investigator: Maksim Mamonkin, PhD Baylor College of Medicine
Principal Investigator: Malcolm K Brenner, MB, PhD Baylor College of Medicine

Partners:

The Methodist Hospital System

Center for Cell and Gene Therapy, Baylor College of Medicine

Locations:

United States, Texas

Study start:
Mar. 1, 2020
Enrollment:
21 participants
Gene editing method:
CRISPR-Cas9
Gene:
CD7
Vector:
No information
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet 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.