RecruitingPhase 1NCT03829540

CD4CAR for CD4+ Leukemia and Lymphoma

A Phase I, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients With Relapsed or Refractory CD4+ Hematological Malignancies


Sponsor

Huda Salman

Enrollment

20 participants

Start Date

Jul 9, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immune cell therapy called CD4CAR — where doctors reprogram your own immune cells to attack a specific kind of blood cancer — in people whose cancer has not responded to standard treatments. **You may be eligible if...** - You are 12 years old or older - You have been diagnosed with a blood cancer involving a type of immune cell called a CD4+ T cell (such as certain leukemias or lymphomas) - Your cancer has come back or stopped responding to chemotherapy or a previous bone marrow transplant - Your heart, kidneys, and liver are functioning well enough to handle the treatment - You do not need extra oxygen while resting **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have an active, uncontrolled infection - You have active hepatitis B or C - You are HIV positive - You have an active autoimmune disease requiring ongoing treatment - You have received another experimental cell or gene therapy in the past 6 months - You have another cancer (besides the T-cell cancer) that required treatment in the last 3 years - You take high-dose steroids on an ongoing basis 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(6)

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

Albert Einstein Health Network

New York, New York, United States

Stony Brook Cancer Center

Stony Brook, 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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NCT03829540


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