Lentivirally Redirected CD123 Autologous T Cells in AML

Inclusion Criteria

• •1. Male or female subjects 18 years of age or older
• •2. Subjects with active acute myeloid leukemia (AML) with no available curative treatment options using currently available therapies. Specifically:
• •1. AML that has not achieved a complete remission or morphologic leukemia free state by ELN criteria (Döhner et al., 2017 Blood, 129(4):424-447); partial remission or refractory disease (including primary refractory) are eligible. Or:
• •2. AML relapsed following allogeneic stem cell transplantation (including MDS evolved to AML post-allogeneic stem cell transplantation). Note: morphologic relapse is not required; persistent/recurrent disease-associated molecular, phenotypic or cytogenetic abnormalities (measurable residual disease, MRD) at any time after allogeneic HCT is eligible
• •3. Subjects with relapsed disease after prior transplant must meet one of the following:
• •4. Subjects must have a suitable stem cell donor available who may donate cells in the event the subject needs to undergo an allogeneic HCT. Donor may be matched or mismatched and must be found to be suitable according to the institution's standard criteria; donors must be fully cleared to proceed as the donor.
• •5. Satisfactory organ functions:
• •1. Creatinine ≤ 1.6 mg/dl
• •2. ALT/AST must be ≤5 x upper limit of normal unless related to disease
• •3. Direct bilirubin or total bilirubin \< 2.0mg/dl, unless subject has Gilbert's syndrome (≤3.0 mg/dL);
• •4. Left ventricular ejection fraction ≥ 40% as confirmed by ECHO/MUGA
• •6. ECOG Performance status 0-2.
• •7. Written informed consent is given.
• •8. No contraindications for leukapheresis.
• •9. Subjects of reproductive potential must agree to use acceptable birth control methods (as described in protocol Section 4.3).