Leukemia Clinical Trials

• 18-74 years with Karnofsky score ≥ 70%

• 75 years and older: KPS ≥ 70%, HCT-CI \< 5 (excluding history of solid tumor), AND not frail by Fried frailty criteria (see Appendix III)

• HLA type C1/C1 or C2/C2

⁃ Note: For easy determination, the definition of HLA-C ligand group assigments is included below:

⁃ HLA-C1 group alleles are defined as HLA-C01, C03, C07, C08, C12, C14, C16 HLA-C2 group alleles are defined as HLA-C02, C04, C05, C06, C15, C17, C18

• adequate liver, renal, pulmonary and cardiac function

• ability to be off glucocorticoids and other immunosuppressive medications indicated for acute or chronic GVHD for at least 28 days prior to the AdaptNK cell infusion

• There must be sufficient time between the most recent therapy and the screening bone marrow as delineated below:

• anti-leukemic systemic cytotoxic chemotherapy - 2 weeks

• Targeted anti-leukemic agents (FLT-3, IDH, menin inhibitors) - 3 half-lives of the medication

• Radiotherapy - 1 week

• donor lymphocyte infusions - 6 weeks

• hematopoietic growth factors (filgrastim, TPO agonists, EPO) - 1 week

• biologic therapy (monoclonal antibodies, T-cell engagers) - 2 weeks

• Immune effector cellular therapy - 4 weeks

• Intrathecal chemotherapy for treatment of active CNS leukemia - there must be at least two CSF samples negative for leukemia separated by one week before enrollment.

• WBC shall be \< 25,000 before infusion. Hydroxyurea is permitted until day -3 to control excess blast proliferation. No other systemic treatment is allowed after the screening bone marrow is performed for inclusion in protocol

• All prior treatment related toxicities should have resolved to ≤ grade 1 prior to study enrollment

• agrees to use of adequate contraception from study enrollment to 4 months after cell infusion

• voluntary written consent