Actively Recruiting
Safety and Efficacy of Expanded KIR-HLA Mismatched Natural Killer Cell Immunotherapy (AdaptNK) for High-Risk Myeloid Diseases as Bridge to Allogeneic Hematopoietic Stem Cell Transplantation
Led by Masonic Cancer Center, University of Minnesota · Updated on 2026-05-19
18
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying an advanced immunotherapy approach using an allogeneic natural killer (NK) cell product called AdaptNK for patients with relapsed or refractory acute myelogenous leukemia (AML). This Phase I/II trial evaluates the safety and effects of AdaptNK cells, which have a special "adaptive" phenotype influenced by cytomegalovirus (CMV), combined with a short course of interleukin-2 (IL-2) after chemotherapy that reduces lymphocytes. The study targets high-risk myeloid diseases and aims to support patients as a bridge to allogeneic stem cell transplantation. Participants receive different dose levels of AdaptNK cells intravenously, ranging from less than 1 x 10^8 up to 3 x 10^9 total nucleated cells. Before this infusion, patients undergo lymphodepleting chemotherapy with cyclophosphamide and fludarabine to prepare the body. After the NK cell infusion, IL-2 is given subcutaneously every other day for three doses to support the NK cells. The study includes multiple dose cohorts to assess safety and determine the maximum tolerated dose. During the trial, participants are closely monitored with regular assessments to measure safety and response to treatment, including checking the maximum tolerated dose over one year and objective response by day 42. The research team tracks any side effects, evaluates how well the therapy is tolerated, and follows participants for safety outcomes. The total duration and detailed scheduling of visits are based on the treatment phases and follow-up assessments outlined in the protocol.
CONDITIONS
Brief Title
Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 74 years with Karnofsky performance score of 70% or higher
- Age 75 years or older with Karnofsky score of 70% or higher, HCT-CI less than 5 (excluding history of solid tumor), and not frail by Fried frailty criteria
- HLA type of C1/C1 or C2/C2
- Adequate liver, kidney, lung, and heart function
- Ability to be off glucocorticoids and other immunosuppressive medications for at least 28 days before AdaptNK infusion
- Sufficient time between most recent therapies and screening bone marrow as defined (e.g., 2 weeks since chemotherapy, 6 weeks since donor lymphocyte infusion)
- White blood cell count less than 25,000 before infusion; hydroxyurea allowed until day -3
- All prior treatment toxicities resolved to grade 1 or less
- Agreement to use adequate contraception from enrollment until 4 months after cell infusion
- Voluntary written informed consent
You will not qualify if you...
- Myeloid neoplasms with known or suspected germline mutations except DDX41, TP53, or RUNX1
- Acute promyelocytic leukemia (APL)
- Heart attack within 6 months before enrollment
- Pregnant or breastfeeding
- Active central nervous system leukemia involvement
- New or worsening lung infiltrates
- Active autoimmune or preexisting inflammatory disease requiring immunosuppressive therapy
- Severe asthma on chronic systemic medications
- HIV-1/2 or hepatitis B/C infection
- Active systemic infections needing treatment
- Use of investigational agents within 14 days before study treatment
- Recent systemic chemotherapy for second malignancies within 1 year unless stable hormonal therapy
- Untreated or active other cancers except certain skin or cervical carcinomas in situ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 2 weeks
Participants receive lymphodepleting chemotherapy followed by AdaptNK cell immunotherapy and IL-2 injections.
1 infusion visit for AdaptNK and multiple IL-2 injections every other day for 3 doses
Duration - Up to 42 days
Participants are monitored for safety and response after treatment.
Follow-up visits for safety and response assessments
Trial Site Locations
Total: 1 location
1
Mark Juckett, MD
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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