Adapt NK for High Risk Myeloid Diseases as Bridge to Allo HSCT

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT07591649
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Acute Myelogenous Leukemia
  • Refractory AML
  • Relapsed Adult AML

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • AdaptNK — BIOLOGICAL
    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.
  • Fludarabine — DRUG
    25 mg/kg administered on days -6, -5, -4, -3 and -2. Part of Lymphodepleting conditioning chemotherapy regimen.
  • Cyclophosphamide — DRUG
    60 mg/kg administered on days -5 and -4. Part of Lymphodepleting conditioning chemotherapy regimen.
  • IL-2 — DRUG
    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 Details

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.

Key Dates

Start date
May 8, 2026
Status verified
May 2026
Primary completion
Mar 1, 2030
Completion
Mar 1, 2035

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level Cohort -1
    Safety dose level. \< 1 x 10\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).
  • Experimental: Dose Level Cohort 1
    2.4 - 3 x 10\^8 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).
  • Experimental: Dose Level Cohort 2
    0.8 - 1 x 10\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).
  • Experimental: Dose Level Cohort 3
    2.4 - 3 x 10\^9 Total Nucleated Cells (TNC) of AdaptNK product administered intravenously (IV).

Primary Outcome Measure

Maximum tolerated dose (MTD) [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mark Juckett, MDMinneapolisMinnesota55455
Mark Juckett, MD
[email protected]
612-676-4200

Find similar trials in Minneapolis, MN

By research site
Mark Juckett, MD· Minneapolis, MN

Related Studies