Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT05010564
Phase
PHASE1
Status
Recruiting
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Conditions

  • Leukemia, B-Cell

Eligibility Criteria

Sex
ALL
Age
12 Months - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy — GENETIC
    Three dose levels will be evaluated with the opportunity to dose de-escalate (dose level -1) for toxicity. DL-1: 3x10\^6 cells/m2 DL1: 1×10\^7 cells/m2 DL2: 3×10\^7 cells/m2 DL3: 1×10\^8 cells/m2 Lymphodepletion chemotherapy consisting of Fludarabine 30 mg/m2 IV once daily x 4 doses; and Cyclophosphamide 500mg/m2 IV once daily x 2 doses (starting with the first dose of fludarabine)must be completed greater than or equal to 48 hours prior to infusion of CAR-T cells.

Study Details

This is a gene transfer study for patients with a type of blood cancer called Acute Lymphoblastic Leukemia (ALL) that has come back or has not gone away after treatment. The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancers. This research study combines two different ways of fighting cancer: antibodies and T cells. Antibodies are types of proteins that protect the body from infectious diseases and possibly cancer. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. Both antibodies and T cells have been used to treat patients with cancers. They have shown promise but have not been strong enough to cure most patients. For example, T lymphocytes can kill cancer cells but there normally are not enough of them to kill all the cancer 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 targets CD19, CD20 and CD22. This antibody sticks to ALL cells because of a substance on the outside of these cells called CD19, CD20 and/or CD22. For this study, the antibody to CD19, CD20 and CD22 has been changed so that instead of floating free in the blood, it is now joined to the T cells. When T-cells contain an antibody that is joined to them, they are called chimeric antigen receptor- T cells or CAR-T cells. In the laboratory, we have also found that T cells work better if we also add proteins that stimulate them. One such protein is called 4-1BB. Adding the 4-1BB molecule makes the cells grow better and last longer in the body, giving them a better chance of killing the leukemia cells. In this study we are going to attach the CD19/CD20/CD22 chimeric receptor that has 4-1BB added to the patient's T cells. We will then test how long the cells last. These T cells, called "TRICAR-ALL" T cells are investigational products not approved by the Food and Drug Administration (FDA) outside the context of a clinical trial.

Key Dates

Start date
Jul 18, 2023
Status verified
Nov 2025
Primary completion
Jul 17, 2026
Completion
Mar 29, 2040

Study Design

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

Arms

  • Experimental: Autologous TRICAR-ALL T-Cells and lymphodepletion chemotherapy
    Three dose levels will be evaluated. The TRICAR-ALL T-cells will be administered after lymphodepletion chemotherapy with Cyclophosphamide and fludarabine.

Primary Outcome Measure

Dose-limiting toxicity (DLT) rate by CTCAE v5.0 [ Time Frame: within 28 days of the TRICAR-ALL T cell infusion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Texas Children's HospitalHoustonTexas77030
Bahey Salem, MD
[email protected]
832-824-1803

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By research site
Texas Children's Hospital· Houston, TX

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