Study 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
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CD4CARBIOLOGICAL
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
Study Locations
| Facility | City | State | Country |
|---|---|---|---|
| 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 |