RecruitingPhase 1NCT06071624

Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.

CD4CAR T Cell Therapy for CMML


Sponsor

Huda Salman

Enrollment

30 participants

Start Date

Feb 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a cutting-edge cell therapy called CD4 CAR T-cell therapy for people with chronic myelomonocytic leukemia (CMML) — a rare blood cancer — whose disease has returned or not responded to standard first-line treatment. This therapy uses the patient's own immune cells, re-engineered to target and destroy cancer cells. **You may be eligible if...** - You are 18 or older - You have CMML that has come back or didn't respond to first-line treatment - Your cancer cells test positive for a protein called CD4 - Your kidney, liver, and heart function are adequate - You do not need supplemental oxygen at rest **You may NOT be eligible if...** - You have active uncontrolled infection - You have had a prior stem cell transplant within a certain timeframe - You have serious heart, liver, or lung problems - You are pregnant or breastfeeding 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 33136

Miami, Florida, United States

Indiana University Melvin and Bren Simon Comprehensive Cancer Center

Indianapolis, Indiana, United States

Albert Einstein Health Network

The Bronx, New York, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06071624


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