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Protocol Details

Phase 1/2 Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults with Relapsed/Refractory Acute Myeloid Leukemia

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0028

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 3 Years
Max Age: 35 Years

Referral Letter Required

No

Population Exclusion(s)

Pregnant Women;
Neonates

Keywords

Children/young adults;
CD33CART cells

Recruitment Keyword(s)

None

Condition(s)

Leukemia;
Neoplasms by Histologic Type;
Neoplasms;
Leukemia, Myeloid, Acute;
Leukemia, Myeloid

Investigational Drug(s)

lentivirally-transduced CD33-redirected CAR-T cells (CD33CART)

Investigational Device(s)

None

Intervention(s)

Biological/Vaccine: CD33CART cell infusion

Supporting Site

National Cancer Institute

Background:

The T cells of a person s immune system can be changed to fight cancer. This is called gene therapy. In this study, T cells will be changed to attack the CD33 marker. This marker is common in acute myeloid leukemia (AML). These new cells are called CD33CART cells. Researchers want to see if this therapy can treat AML that is not responding to standard therapy or has recurred after prior treatment.

Objective:

To learn if CD33CART cells are safe for people with AML.

Eligibility:

People ages 3-35 years who have AML with the CD33 marker, whose AML has not been cured with standard therapy

Design:

Participants will be screened with some or all of the following:

-physical exam

-medical history

-blood and urine tests

-heart, liver, and lung tests

-assessment of well-being and ability to perform daily activities

-MRI, CT, or PET

-bone marrow biopsy or aspiration

-spinal tap

Some screening tests will be repeated throughout the study.

Participants will have T cells taken. For this, needles are put in 2 different veins or the patient will have a central line placed. Blood is taken from one vein. A machine separates the T cells from the other parts of the blood. The rest of the blood is returned to the other vein.

Participants will get 2 chemotherapy drugs by IV for 3 days. Two days later they will get CD33CART cells by IV. They will have blood tests daily for 14 days and then at least twice weekly for 14 days.

Participants will take neurologic tests and fill out questionnaires.

Participants will have follow-up visits at months 2, 3, 6, 9, 18, and 24, then yearly for 5 years. They will be monitored for 15 years.

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Eligibility

Eligibility:

Subjects >=3 year to <=35 years of age with AML in 2nd or greater relapse or refractory to 2 or more induction attempts without central nervous system (CNS) CNS3 disease and who have a suitable allogeneic HCT donor and a performance status of >= 50% may be eligible for study.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Nirali N. Shah, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 1-5750
10 CENTER DR
BETHESDA MD 20892
(240) 760-6970
shahnn@mail.nih.gov

NCI Pediatric Leukemia, Lymphoma Transpl
National Cancer Institute (NCI)

(240) 760-6970
ncilltct@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT03971799

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