NCT07591649

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
106mo left

Started May 2026

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 18, 2026

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2030

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2035

Last Updated

May 19, 2026

Status Verified

May 1, 2026

Enrollment Period

3.8 years

First QC Date

May 11, 2026

Last Update Submit

May 15, 2026

Conditions

Refractory AMLAcute Myelogenous LeukemiaRelapsed Adult AML

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 year

Secondary Outcomes (2)

  • Objective response (OR)

    Day 42

  • Safety of AdaptNK

    Day 42

Other Outcomes (4)

  • Overall survival

    1 year

  • Overall survival

    2 year

  • Leukemia free survival (LFS)

    1 year

  • +1 more other outcomes

Study Arms (4)

Dose Level Cohort -1

EXPERIMENTAL

Safety dose level. \< 1 x 10\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).

Biological: AdaptNKDrug: FludarabineDrug: CyclophosphamideDrug: IL-2

Dose Level Cohort 1

EXPERIMENTAL

2.4 - 3 x 10\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).

Biological: AdaptNKDrug: FludarabineDrug: CyclophosphamideDrug: IL-2

Dose Level Cohort 2

EXPERIMENTAL

0.8 - 1 x 10\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).

Biological: AdaptNKDrug: FludarabineDrug: CyclophosphamideDrug: IL-2

Dose Level Cohort 3

EXPERIMENTAL

2.4 - 3 x 10\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).

Biological: AdaptNKDrug: FludarabineDrug: CyclophosphamideDrug: IL-2

Interventions

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.

Dose Level Cohort -1Dose Level Cohort 1Dose Level Cohort 2Dose Level Cohort 3
FludarabineDRUG

25 mg/kg administered on days -6, -5, -4, -3 and -2. Part of Lymphodepleting conditioning chemotherapy regimen.

Dose Level Cohort -1Dose Level Cohort 1Dose Level Cohort 2Dose Level Cohort 3
CyclophosphamideDRUG

60 mg/kg administered on days -5 and -4. Part of Lymphodepleting conditioning chemotherapy regimen.

Dose Level Cohort -1Dose Level Cohort 1Dose Level Cohort 2Dose Level Cohort 3
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.

Dose Level Cohort -1Dose Level Cohort 1Dose Level Cohort 2Dose Level Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years with Karnofsky score ≥ 70%
  • 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
  • +4 more criteria

You may not qualify if:

  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mark Juckett, MD

Minneapolis, Minnesota, 55455, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

fludarabineCyclophosphamideInterleukin-2

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus CompoundsInterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological Factors

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2026

First Posted

May 18, 2026

Study Start

May 8, 2026

Primary Completion (Estimated)

March 1, 2030

Study Completion (Estimated)

March 1, 2035

Last Updated

May 19, 2026

Record last verified: 2026-05

Locations

US(1)