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)
CD4 negative CMML
Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy
Uncontrolled active infection necessitating systemic therapy
Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit
Huda Salman
Lead sponsor
Indiana University
Sponsor institution
iCell Gene Therapeutics
Collaborator
The Leukemia and Lymphoma Society
Collaborator