RecruitingPhase 1NCT06197672

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory AML as a Bridge to Allogeneic Stem Cell Transplant


Sponsor

Huda Salman

Enrollment

30 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study tests a CAR-T cell therapy — a form of personalized immune cell treatment — that targets the CD4 protein on leukemia cells in patients with acute myeloid leukemia (AML) that has not responded to standard treatment. **You may be eligible if...** - You are 12 years of age or older - You have been diagnosed with CD4-positive AML - Your leukemia has not responded to or came back after standard first-line treatment (such as induction chemotherapy or azacitidine plus venetoclax) - You are able to provide written consent **You may NOT be eligible if...** - Your AML does not have the CD4 protein on the cancer cells - You have not yet tried standard first-line treatment - You have severe other medical conditions that would make this therapy unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALCD4CAR

CD4CAR cells transduced with a lentiviral vector to express the single-chain variable fragment (scFv) nucleotide sequence of the anti-CD4 molecule derived from humanized monoclonal ibalizumab and the intracellular domains of CD28 and 4-1BB co-activators fused to the CD3ζ T-cell activation signaling domain administered by IV infusions as a single dose


Locations(4)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Riley Hospital for Children

Indianapolis, Indiana, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06197672


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