Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMasonic Cancer Center, University of Minnesota
About this trial
This is a multi-institutional Phase I/II study of an allogeneic KIR-HLA mismatched NK cell infusion (AdaptNK) and a short course of subcutaneous interleukin-2 (IL-2) administered after lymphodepleting chemotherapy \[cyclophosphamide (CY)/fludarabine (FLU)\] in patients with relapsed or refractory acute myelogenous leukemia (AML). AdaptNK is a natural killer (NK) cell product that is enriched for NK cells with an "adaptive", or human cytomegalovirus (CMV)-induced, phenotype.
Eligibility criteria
Qualifiers
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
adequate liver, renal, pulmonary and cardiac function
Disqualifiers
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
Trial design
Treatments tested in this trial
- AdaptNK
- Fludarabine
- Cyclophosphamide
- IL-2
Treatment groups
18 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov