Chimeric Antigen Receptor T-cells for The Treatment of AML Expressing CLL-1 Antigen
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|ClinicalTrials.gov Identifier: NCT04219163|
Recruitment Status : Recruiting
First Posted : January 6, 2020
Last Update Posted : September 1, 2020
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 Drug Administration.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: CLL-1.CAR T cells||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Chimeric Antigen Receptor T-cells for The Treatment of Acute Myeloid Leukemia Expressing CLL-1 Antigen|
|Actual Study Start Date :||July 9, 2020|
|Estimated Primary Completion Date :||July 31, 2024|
|Estimated Study Completion Date :||July 31, 2038|
Biological: CLL-1.CAR T cells
Dose escalation study with 3 dose levels:
DL1: 1x 10^7 cells/m^2, DL2: 3x10^7 cells/m^2, DL3: 1x 10^8 cells/m^2
If excessive dose limiting toxicity attributed to the product occurs at dose level one, we will request permission from FDA to treat at dose level -1: 5×106 cells/m2
- Dose limiting toxicity (DLT) rate [ Time Frame: 4 weeks post T cell infusion ]To assess dose limiting toxicities per protocol-defined CLL-1.CAR T related adverse events and CTCAE v5.0
- Overall Response Rate [ Time Frame: 4 weeks post T cell infusion ]To measure the anti-tumor effects of CLL-1.CAR T-cells in patients with acute myeloid malignancies.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04219163
|Contact: LaQuisa Hill, MD||713-441-1450||LaQuisa.Hill@bcm.edu|
|United States, Texas|
|Texas Children's Hospital||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: LaQuisa Hill, MD 713-441-1450 LaQuisa.Hill@bcm.edu|
|Principal Investigator:||LaQuisa Hill, MD||Cell and Gene Therapy, Baylor College of Medicine|