Clinical trial · Interventional
Haploidentical Donor Natural Killer Cell Infusion With IL-15 in Acute Myelogenous Leukemia (AML)
Haploidentical Donor Natural Killer (NK) Cell Infusion With Intravenous 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)
This is a single center, "modified standard design" dose escalation study designed to determine the maximum tolerated, minimum efficacious dose (MTD/MED) of IL-15 (Intravenous Recombinant Human IL-15) and incidence of donor natural killer (NK) cell expansion by day +14 when given after haploidentical donor NK cells in patients with relapse or refractory acute myelogenous leukemia (AML).
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intravenous Recombinant Human IL-15 (rhIL-15) | Biological | — | UNRESOLVED |
| Preparative Regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IL-15 Patients with AML
- description
- Adults with Refractory or Relapsed Acute Myelogenous Leukemia (AML) treated with preparative regimen and Intravenous Recombinant Human IL-15 (rhIL-15)
- interventionNames
- Drug: Preparative Regimen
- Biological: Intravenous Recombinant Human IL-15 (rhIL-15)
Primary outcomes (1)
- measure
- Maximum Tolerated/Minimum Efficacious Dose
- timeFrame
- Day 42
- description
- Determine the maximum tolerated, minimum efficacious dose (MTD/MED) of recombinant human IL-15; dose limiting toxicity (DLT) occurring during the first 42 days after the NK cell infusion; MED = if 2 of 3 patients or 4 of 6 patients has an in vivo NK cell count \>2500, then dose escalation with cease as it will be in the range of a biologic dose which may achieve the goal of in vivo expansion without pushing IL-15 doses higher to toxicity.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age * Meets one of the following disease criteria: * Primary acute myelogenous leukemia (AML) induction failure: no complete response (CR )after 2 or more induction attempts * Relapsed AML or Secondary AML (from MDS or treatment-related): not in CR after 1 or more cycles of standard induction therapy. For patients \> 60 years of age the 1 cycle of standard chemotherapy is not required if either of the following is met: * relapse within 6 months of last chemotherapy * blast count \<30% within 10 days of starting protocol * AML relapsed \> 2 months after transplant who do not have the option of donor lymphocyte infusions (e.g. recipients of autologous or umbilical cord blood \[UCB\] transplants) Patients with prior central nervous system (CNS) involvement are eligible provided that it has been treated and cerebrospinal fluid (CSF) is clear for at least 2 weeks prior to enrollment. CNS therapy (chemotherapy or radiation) should continue as medically indicated during the study treatment. * Available related HLA-haploidentical donor (3-5 of 6 HLA-A, B and C) * Karnofsky Performance Status \> 50% * Adequate organ function defined as: * Creatinine: ≤ 2.0 mg/dL * Hepatic: Liver function tests (LFT's) \< 5 times upper limit of institutional normal (ULN) * Pulmonary Function: oxygen saturation ≥ 90% on room air and pulmonary function \>50% corrected DLCO and FEV1 Testing required only if symptomatic or prior known impairment. * Cardiac Function: Ejection fraction (EF) ≥ 40%, no uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities * Able to be off prednisone or other immunosuppressive medications for at least 3 days prior to Natural Killer (NK) cell infusion (excluding preparative regimen pre-medications) * Women of child bearing potential and men with partners of child bearing potential must agree to use effective contraception during therapy and for 4 months after completion of therapy. * Voluntary written consent Exclusion Criteria: * Bi-phenotypic acute leukemia * Transplant \< 60 days prior to study enrollment * Pregnant or breastfeeding - The agents used in this study include those that fall under Pregnancy Category D - have known teratogenic potential. Women of child bearing potential must have a negative pregnancy test within 14 days of study treatment start * Active autoimmune disease * History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible) * New or progressive pulmonary infiltrates on screening chest x-ray or chest CT scan that has not been evaluated with bronchoscopy, if feasible. Infiltrates attributed to infection must be stable/improving (with associated clinical improvement) after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections). Surgical resection waives any waiting requirements. * Uncontrolled bacterial or viral infections - chronic asymptomatic viral hepatitis is allowed * Pleural effusion large enough to be detectable on chest x-ray * Known hypersensitivity to any of the study agents used * Received investigational drugs within the 14 days before enrollment * 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 (low resolution) * Not pregnant * Agree to undergo donor viral screening panel * Able and willing to undergo apheresis * Voluntary written consent
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