Relapsed Adult AMLPhase 1/2NCT07591649
Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT
A Phase 1/2 study testing AdaptNK, Fludarabine and Cyclophosphamide in people with Relapsed Adult AML and Refractory AML, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Adult AML, Refractory AML, Acute Myelogenous Leukemia
- What is being tested?
- AdaptNK, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2026to 1 Mar 2035
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mark Juckett, MD
Minneapolis, Minnesota, 55455
Mark Juckett, MD, 612-676-4200, juck0001@umn.edu
About this study
Official title: 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
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.
- Being tested
- AdaptNK, Fludarabine, Cyclophosphamide, IL-2
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdaptNKBiological
The NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a cryopreserved pool.
of third-party donors that are seropositive for cytomegalovirus (CMV+), have NK cells expressing >20% NKG2C and >30% single-self KIR and depleted from CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells.
FludarabineDrug
25 mg/kg administered on days -6, -5, -4, -3 and -2. Part of Lymphodepleting conditioning chemotherapy regimen.
CyclophosphamideDrug
60 mg/kg administered on days -5 and -4. Part of Lymphodepleting conditioning chemotherapy regimen.
IL-2Drug
IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 3 doses with Dose 1 on Day 0 (no sooner than 4 hours post cell infusion) with the last dose no later than Day +8.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level Cohort -1 | Experimental | Safety dose level. < 1 x 10^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). Receives: Biological: AdaptNK; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: IL-2 |
| Dose Level Cohort 1 | Experimental | 2.4 - 3 x 10^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). Receives: Biological: AdaptNK; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: IL-2 |
| Dose Level Cohort 2 | Experimental | 0.8 - 1 x 10^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). Receives: Biological: AdaptNK; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: IL-2 |
| Dose Level Cohort 3 | Experimental | 2.4 - 3 x 10^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). Receives: Biological: AdaptNK; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: IL-2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
The primary objective of the study is to assess the safety and determine the maximum tolerated dose (MTD) of AdaptNK administered as a single infusion intravenously (IV) to KIR-HLA mismatched patients with relapsed or refractory AML.
Measured: 1 year
Secondary outcomes (2)
Objective response (OR)
includes complete remission with or without hematologic recovery (CR or CRi) or partial remission (PR)
Measured: Day 42
Safety of AdaptNK
measured by rate of treatment related mortality (TRM)
Measured: Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start8 May 2026
- Primary completion1 Mar 2030 (estimated)
- Study completion1 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Adult AMLStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07591649
- Sponsor's protocol ID
- 2023LS005
- Status last verified
- May 2026
- First submitted
- 11 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07591649
- Acronym / sponsor ID
- 2023LS005
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 8 May 2026 (actual)
- Primary completion
- 1 Mar 2030 (estimated)
- Study completion
- 1 Mar 2035 (estimated)
- First posted
- 18 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Dose Level Cohort -1 | Experimental | Biological: AdaptNK, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: IL-2Safety dose level. < 1 x 10^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). |
| Dose Level Cohort 1 | Experimental | Biological: AdaptNK, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: IL-22.4 - 3 x 10^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). |
| Dose Level Cohort 2 | Experimental | Biological: AdaptNK, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: IL-20.8 - 1 x 10^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). |
| Dose Level Cohort 3 | Experimental | Biological: AdaptNK, Drug: Fludarabine, Drug: Cyclophosphamide, Drug: IL-22.4 - 3 x 10^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdaptNKThe NK cell product is comprised of peripheral blood (PB) leukocytes sourced from a cryopreserved pool. of third-party donors that are seropositive for cytomegalovirus (CMV+), have NK cells expressing >20% NKG2C and >30% single-self KIR and depleted from CD3+ (T-lymphocytes) and CD19+ (B-lymphocytes) cells. | Biological | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2, Dose Level Cohort 3 |
| Fludarabine25 mg/kg administered on days -6, -5, -4, -3 and -2. Part of Lymphodepleting conditioning chemotherapy regimen. | Drug | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2, Dose Level Cohort 3 |
| Cyclophosphamide60 mg/kg administered on days -5 and -4. Part of Lymphodepleting conditioning chemotherapy regimen. | Drug | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2, Dose Level Cohort 3 |
| IL-2IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 3 doses with Dose 1 on Day 0 (no sooner than 4 hours post cell infusion) with the last dose no later than Day +8. | Drug | Dose Level Cohort -1, Dose Level Cohort 1, Dose Level Cohort 2, Dose Level Cohort 3 |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: 1 year
The primary objective of the study is to assess the safety and determine the maximum tolerated dose (MTD) of AdaptNK administered as a single infusion intravenously (IV) to KIR-HLA mismatched patients with relapsed or refractory AML.
2 secondary outcomes
Objective response (OR)
Time frame: Day 42
Safety of AdaptNK
Time frame: Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AdaptNK, Fludarabine and Cyclophosphamide in people with Relapsed Adult AML and Refractory AML, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose (MTD) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.