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

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT03690011
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CD7.CAR/28zeta CAR T cells — GENETIC
    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

Study Details

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.

Key Dates

Start date
Aug 2, 2021
Status verified
Oct 2025
Primary completion
May 1, 2026
Completion
May 1, 2040

Study Design

Enrollment
27 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD7.CAR/28zeta CAR T Cells
    Four dose levels will be evaluated. The T cells will be administered following lymphodepleting chemotherapy with cyclophosphamide and fludarabine.

Primary Outcome Measure

Number of patients with dose limiting toxicity [ Time Frame: 4 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
LaQuisa HIll, MD
[email protected]
832-824-4670
Texas Children's HospitalHoustonTexas77030
Rayne Rouce, MD
[email protected]
832-824-4716

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