Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatm
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.
| Condition(s) | Chronic Myelomonocytic Leukemia |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 if within 45 days of initial assessment 9. Adequate venous access for apheresis and no other contraindications for leukapheresis Exclusion Criteria: 1. CD4 negative CMML 2. Pregnant or lactating women. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Huda Salman |
| Locations | Miami, Florida, United States; Indianapolis, Indiana, United States; The Bronx, New York, United States; Houston, Texas, United States |
| Start date | 2024-02-21 |
| NCT ID | NCT06071624 |
| Official listing | https://clinicaltrials.gov/study/NCT06071624 |