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NCT04219163 · ClinicalTrials.gov registry record · Phase 1
Chimeric Antigen Receptor T-cells for The Treatment of AML Expressing CLL-1 Antigen
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 18
- Enrollment target
- 1
- Study location
NCT04219163: Active Phase 1 study of Acute Myeloid Leukemia, sponsored by Baylor College of Medicine.
NCT04219163 is a Phase 1 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 18 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04219163, a Phase 1 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 18 participants
- Enrollment target
- 1
- Study location
Study Summary
Patients eligible for this study have a type of blood cancer Acute Myeloid Leukemia (AML) which has come back or has not gone away after treatment. The body has different ways of fighting disease and infection, and this research study combines two different ways of fighting cancer with antibodies and T cells with the hope that they will work together. T cells (also called T lymphocytes) are special infection-fighting blood cells that can kill other cells including tumor cells. Antibodies are types of proteins that protect the body from bacterial and other infectious diseases. 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 when used alone. T lymphocytes 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 targets CLL-1. This antibody sticks to AML cells because of a substance (protein) on the outside of these cells called CLL-1. For this study, the antibody to CLL-1 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, the investigators have also found that T cells work better if proteins that stimulate T cells are also added, 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 we are going to attach the CLL-1 chimeric receptor that has CD28 added to it to the patient's T cells. We will then test how long the cells last. These CLL-1 chimeric antigen receptor T cells with CD28 are investigational products not approved by the Food and Dr
Primary Outcome
To assess dose limiting toxicities per protocol-defined CLL-1.CAR T related adverse events and CTCAE v5.0
Conditions Studied
Interventions
- BIOLOGICAL CLL-1.CAR T cells
Study Locations (1)
Texas
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2020-07-09 |
| Est. Completion | 2038-07-31 |
| Phase | Phase 1 |
What the registry record for NCT04219163 still lists
NCT04219163 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which CLL-1.CAR T cells is the first listed.
NCT04219163 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04219163 about?
NCT04219163 is a clinical study titled "Chimeric Antigen Receptor T-cells for The Treatment of AML Expressing CLL-1 Antigen". Patients eligible for this study have a type of blood cancer Acute Myeloid Leukemia (AML) which has come back or has not gone away after treatment. The body has different ways of fighting disease and infection, and this research study combines two different ways of fighting cancer with antibodies a...
What is the current status of trial NCT04219163?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 18 participants. The study started on 2020-07-09. Estimated completion is 2038-07-31.
What conditions does trial NCT04219163 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT04219163?
The interventions under investigation include: CLL-1.CAR T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04219163?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04219163 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
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Where NCT04219163's enrollment target sits among peer trials
18 259th of 306 higher than 40 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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