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NCT05010564 · ClinicalTrials.gov registry record · Phase 1
Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)
A Phase 1 study of Leukemia, B-cell, sponsored by Baylor College of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT05010564 is a Phase 1 study of Leukemia, B-cell that is actively recruiting participants, run by Baylor College of Medicine. The registered enrollment target is 38 participants, below the 363-participant average among 3 other Leukemia, B-cell trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05010564, a Phase 1 study of Leukemia, B-cell, is actively recruiting participants, sponsored by Baylor College of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
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 i
Conditions Studied
Interventions
- GENETIC Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2023-07-18 |
| Est. Completion | 2040-03-29 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05010564
The ClinicalTrials.gov registry entry for NCT05010564 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 363-participant average among 3 other Leukemia, B-cell trials with a reported enrollment target (90% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Leukemia, B-cell appearing as the primary indexed condition, and to 1 intervention - of which Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy is the first listed.
NCT05010564 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT05010564 about?
NCT05010564 is a clinical study titled "Trivalent CAR-T Cell in Acute B-Lineage Leukemia (TRICAR-ALL)". 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 st...
What is the current status of trial NCT05010564?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2023-07-18. Estimated completion is 2040-03-29.
What conditions does trial NCT05010564 study?
This clinical trial studies the following conditions: Leukemia, B-cell.
What interventions are being tested in trial NCT05010564?
The interventions under investigation include: Autologous TRICAR-ALL T-cells and lymphodepletion chemotherapy (GENETIC).
Who is sponsoring clinical trial NCT05010564?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05010564 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.