FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia

Inclusion Criteria

• •Acute myeloid leukemia relapsed/refractory after 2 lines of therapy; with CD38 expression
• •CD38 expression is defined by ≥20% of malignant cells with CD38 expression by flow cytometry on the most recent marrow biopsy (within 30 days of enrollment - archived or fresh).
• •Relapsed/refractory is defined as failure to achieve at least a Morphological Leukemia Free State (MLFS) or reverting from MLFS.
• •Lines of therapy are defined as (must have had 2 prior therapies):
• •* One cycle of Intensive induction chemotherapy such as 7+3, 5+2, MEC, FLAG, FLAG-Ida, CLAG ± small molecule inhibitor
• •* Four weeks of HMA-based induction ± small molecule inhibitor
• •* Hematopoietic stem cell transplantation (HSCT) if relapse that occurs \> 90 days after HSCT
• •* Gemtuzumab Ozogamicin
• •* LDAC + glasdegib
• •* Biomarker-specific targeted agents (FLT3 inhibitors, IDH1/2 inhibitors, others if available)
• •* Other treatments could be considered after discussion with the PI
• •Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
• •Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
• •Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and \< 16 years of age
• •Evidence of adequate organ function within 14 days of starting study treatment defined as:
• •* Estimated Glomerular Filtration Rate (estimated creatinine clearance) ≥50 mL/min/1.73m\^2
• •* Total bilirubin ≤ 5 × upper limit normal (ULN), not applicable for patients with Gilbert's syndrome
• •* AST ≤3 × ULN and ALT ≤ 3 × ULN, not applicable if determined to be directly due to underlying malignancy
• •* LVEF ≥ 40% by echocardiogram or MUGA
• •Contraceptive use by men or women
• •* Female subjects: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of cyclophosphamide (CY), at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• •* Male subjects: Males with a female partner of childbearing potential or a pregnant female partner must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 4 months after the final dose of CY and at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
• •Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
• •Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.