Cell Therapy for High Risk T-Cell Malignancies Using CD7-Specific CAR Expressed On Autologous T Cells

Summary

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.

In this study, investigators attach the CD7 chimeric receptor with CD28 added to it to T cells. 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.

Conditions

• T-cell Acute Lymphoblastic Lymphoma
• T-non-Hodgkin Lymphoma
• T-cell Acute Lymphoblastic Leukemia

Interventions

GENETIC

CD7.CAR/28zeta CAR T cells

Three dose levels will be evaluated: * Dose level one: 1×10\^7 cells/m\^2 * Dose level two: 3×10\^7 cells/m\^2 * Dose level three: 5x10\^7 cells/m\^2 * Dose level four: 1×10\^8 cells/m\^2

Sponsors & Collaborators

• The Methodist Hospital Research Institute

  collaborator OTHER

• Center for Cell and Gene Therapy, Baylor College of Medicine

  collaborator OTHER

• The Leukemia and Lymphoma Society

  collaborator OTHER

• Cancer Prevention Research Institute of Texas

  collaborator OTHER

• Baylor College of Medicine

  lead OTHER

Principal Investigators

• Rayne Rouce, MD · Pediatrics, Baylor College of Medicine

• LaQuisa Hill, MD · Baylor College of Medicine

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-08-02

Primary Completion

2026-05-01

Completion

2040-05-01

FDA Drug

Yes

Countries

• United States

Study Locations