CD4CAR T Cell Therapy for CMML
Huda Salman
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.
Description
The study will be performed as a dose-escalation protocol. Due to the relatively low incidence and prevalence of cluster of differentiation 4-positive (CD4+) hematological malignancies and the associated aggressive nature of these diseases and the sequel of treatment failure, the investigators expect to recruit 20 subjects at Indiana University with an expected dropout rate of 25% primarily due to rapid progression or death and screen and or manufacturing failure. Taking this into account, the investigators expect to treat 15 subjects. The study will utilize autologous CD4CAR T-cells that are…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. ≥ 18 years old at the time of informed consent 2. Ability to provide written informed consent and HIPAA authorization 3. Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment. 4. Creatinine clearance of ≥ 60 ml/min (or otherwise non clinically significant, per study investigator) 5. ALT/AST \< 3 x ULN 6. Bilirubin \< 2 x ULN 7. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion. 8. Adequate cardiac function with EF of ≥50%. This will not have to be repeated i…
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 33136Miami, Florida
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana
- Albert Einstein Health NetworkThe Bronx, New York
- The University of Texas MD Anderson Cancer CenterHouston, Texas