Clinical trial · Interventional
MT2014-25: Haplo NK With SQ IL-15 in Adult Relapsed or Refractory AML Patients
MT2014-25: Haploidentical Donor Natural Killer (NK) Cell Infusion With Subcutaneous Recombinant Human IL-15 (rhIL-15) in Adults With Refractory or Relapsed Acute Myelogenous Leukemia (AML)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A phase II trial of CD3/CD19 depleted, IL-15 activated, donor natural killer (NK) cells in adults and subcutaneous IL-15 given after a preparative regimen for the treatment of relapsed or refractory acute myelogenous leukemia (AML). The primary objective is to study the potential efficacy of NK cells and IL-15 to achieve complete remission while maintaining safety.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myelogenous Leukemia | Acute Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-15 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Preparative Regimen and SubQ rHuIL-15
- description
- Preparative Regimen of Fludarabine and Cyclophosphamide IL-15 Activation of Donor NK Cells: IL-15 to Facilitate NK Cell Survival and Expansion
- interventionNames
- Biological: IL-15
Primary outcomes (1)
- measure
- < 5% Marrow Blast, no Circulating Peripheral Blasts and Neutrophil Count of > 1 x 10^9/L
- timeFrame
- Day 42 post NK cell infusion
- description
- Without platelet recovery
Secondary outcomes (4)
- measure
- In Vivo Expansion (>100) of NK Cells (Defined at CD56+/CD3- Lymphocytes)
- timeFrame
- Day 14 post NK cell infusion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria (Recipient):
* Meets ONE of the following disease criteria:
1. Primary AML induction failure: no CR after 2 or more induction attempts
2. Relapsed AML or Secondary AML (from MDS or treatment related): not in CR after 1 or more cycles of standard re-induction therapy
3. AML relapsed \> 2 months after transplant: No re-induction required, and no more than 1 re-induction cycle is allowed.
4. Relapsed AML for patients \> 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following criteria is met:
* Relapse within 6 months of last chemotherapy
* BM blast count \< 30% within 10 days of starting protocol therapy
* Available related HLA-haploidentical donor (aged 14 to 75 years) by at least Class I serologic typing at the A\&B locus
* Karnofsky Performance Status ≥ 60%
* Patients must have adequate organ within 14 days (28 days for pulmonary and cardiac) of study registration
* Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to NK cell infusion (excluding preparative regimen pre-medications).
* Agrees to use contraception prior to study entry and for the duration of study participation.
Exclusion Criteria (Recipient):
* Bi-phenotypic acute leukemia.
* Transplant \< 60 days prior to study enrollment.
* Active autoimmune disease.
* History of severe asthma
* Uncontrolled intercurrent illness
* New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy
* Pleural effusion large enough to be detectable on chest x-ray.
* Pregnant women
* History of HIV, active or chronic hepatitis B, hepatitis C or HTLV-I infection
* Known hypersensitivity to any of the study agents used
* Received investigational drugs within the 14 days of study registration.
* Known active CNS involvement.
Criteria For Initial Donor Selection:
* Related donors (sibling, parent, offspring, parent or offspring of an HLA identical sibling).
* 14-75 years of age.
* At least 40 kilogram body weight.
* In general good health as determined by the evaluating medical provider.
* HLA-haploidentical donor/recipient match by at least Class I serologic typing at the A\&B locus.
* Not pregnant.
* Able and willing to undergo apheresis.References
Publications (1)
- DERIVEDCooley S, He F, Bachanova V, Vercellotti GM, DeFor TE, Curtsinger JM, Robertson P, Grzywacz B, Conlon KC, Waldmann TA, McKenna DH, Blazar BR, Weisdorf DJ, Miller JS. First-in-human trial of rhIL-15 and haploidentical natural killer cell therapy for advanced acute myeloid leukemia. Blood Adv. 2019 Jul 9;3(13):1970-1980. doi: 10.1182/bloodadvances.2018028332. PMID 31266741