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

NCT05010564 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2025-11-13

No results posted yet for this study

Summary

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.

Conditions

  • Leukemia, B-Cell

Interventions

GENETIC

Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy

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.

Sponsors & Collaborators

  • Texas Children's Cancer Center

    collaborator OTHER

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Bahey Salem, MD · Baylor College of Medicine

  • Nabil Ahmed, MD · Baylor College of Medicine

  • Meenakshi Hegde, MD · Baylor College of Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-18
Primary Completion
2026-07-17
Completion
2040-03-29
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05010564 on ClinicalTrials.gov