Table 2

IL-15-based clinical trial

Clinical trialDosing regimenTumor typePhaseEfficiencySide effectsReference
NCT02359822Subcutaneous rhIL-15Acute myeloid leukemiaPhase 1/240% remissionCRS 56%
Neurotoxicity 33%
NCT01385423Intravenous rhIL-15Acute myeloid leukemiaPhase 1/232% complete remissionNo 90
NTC03388632Intravenous Bolus rhIL-15Metastatic malignanciesPhase 1Stable Disease3 µg/kg thrombocytopenia
0.3 µg/kg no side effects
NCT01572493Continuous intravenous infusion rhIL-15Metastatic malignanciesPhase 1Significant expansion of CD8+ and NK cell30% serious adverse events 92
NCT01021059Bolus infusion rhIL-15Metastatic melanoma and RCCPhase 1Dramatic expansion of NK and γδ T cells3 µg/kg thrombocytopenia
0.3 µg/mL no side effects
NCT01727076Subcutaneous rhIL-15Metastatic malignanciesPhase 1Stable disease dramatic NK expansion and discrete CD8+T cells expansionGrade 2: Pancreatits
Grade 3: cardiac chest pain
NCT01369888CY+Fludarabine+TILs+rhIL-15MelanomaPhase 1autoimmune toxicity 101
NCT01875601Intravenous autologous NK cell infusion+rhIL-15Solid tumors, brain tumors, sarcoma, pediatric cancers, neuroblastomaPhase 1Safety 94
NCT01727076Subcutaneous N-803Metastatic malignanciesPhase 1NK expansionInjection skin rash 95
NTC01727076Intravenous N-803Metastatic malignanciesPhase 1NK expansionNausea, fatigue 95
NTC01885897Intravenous N-803Hematologic malignancies relapsing after allo-hematopoietic cell transplantation (HCT)Phase 1Clearance of lung metastasis in two patients.
Modest expansion of NK and CD8+T cells
Fever chills and rigors 96
NCT01885897Subcutaneous H-803Hematologic malignancies relapsing after allo-HCTPhase 1Sustained expansion of NK and CD8+T cellsInjection skin rash 96
NCT02523469Subcutaneous H-803+PD1 BlockadeNon-small-cell lung carcinomaPhase 1bReinduction of response to PD-1 blockadeInjection skin rash 100
  • HCT, allo-hematopoietic cell transplantation; NK, natural killer; RCC, renal clear carcinoma cell; rhIL-15, human recombinant interleukin-15.