Study 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.
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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 |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | United States |