Immune cell 'Bridge' offers new hope for tough leukemia

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * Myeloid neoplasms with known or strongly suspected germline background, except DDX41, TP53, or RUNX1. * Acute promyelocytic leukemia (APL) * myocardial infarction (MI) within previous 6 months of study enrollment * pregnant or breastfeeding * Active CNS involvement with AML * new or progressive pulmonary infiltrates * active autoimmune disease requiring immunosuppressive therapy * Preexisting inflammatory disease requiring immunosuppressive therapy * history of severe asthma and currently on chronic systemic medications * HIV-1/2 positivity or hepatitis C/B * active systemic infections requiring anti-infective treatment * received any investigational agent within the 14 days before the start of study treatment (1st dose of fludarabine) * Patients with second malignancies are excluded if they have required systemic cytotoxic chemotherapy within 1 year or if they are not in remission * Exception: patients that are on stable dosing of hormonal therapy (e.g. aromatase inhibitor or antiandrogen therapy) for active breast or prostate cancer for 1 year are eligible. * Patients with excised basal cell or squamous cell carcinoma of the skin are eligible. * Patients with excised carcinoma in situ of the cervix or breast are eligible. * Patients with untreated T1a or T1b prostate cancer are eligible.