CD4CAR T Cell Therapy for CMML
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.
• ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment.
• Creatinine clearance of ≥ 60 ml/min (or otherwise non clinically significant, per study investigator)
• ALT/AST \< 3 x ULN
• Bilirubin \< 2 x ULN
• No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion.
• Adequate cardiac function with EF of ≥50%. This will not have to be repeated if within 45 days of initial assessment
• Adequate venous access for apheresis and no other contraindications for leukapheresis