Table 2.
IL-15-based clinical trial
| Clinical trial | Dosing regimen | Tumor type | Phase | Efficiency | Side effects | Reference |
| NCT02359822 | Subcutaneous rhIL-15 | Acute myeloid leukemia | Phase 1/2 | 40% remission | CRS 56% Neurotoxicity 33% |
90 |
| NCT01385423 | Intravenous rhIL-15 | Acute myeloid leukemia | Phase 1/2 | 32% complete remission | No | 90 |
| NTC03388632 | Intravenous Bolus rhIL-15 | Metastatic malignancies | Phase 1 | Stable Disease | 3 µg/kg thrombocytopenia +hypotension 0.3 µg/kg no side effects |
91 |
| NCT01572493 | Continuous intravenous infusion rhIL-15 | Metastatic malignancies | Phase 1 | Significant expansion of CD8+ and NK cell | 30% serious adverse events | 92 |
| NCT01021059 | Bolus infusion rhIL-15 | Metastatic melanoma and RCC | Phase 1 | Dramatic expansion of NK and γδ T cells | 3 µg/kg thrombocytopenia +hypotension 0.3 µg/mL no side effects |
93 |
| NCT01727076 | Subcutaneous rhIL-15 | Metastatic malignancies | Phase 1 | Stable disease dramatic NK expansion and discrete CD8+T cells expansion | Grade 2: Pancreatits Grade 3: cardiac chest pain |
98 |
| NCT01369888 | CY+Fludarabine+TILs+rhIL-15 | Melanoma | Phase 1 | autoimmune toxicity | 101 | |
| NCT01875601 | Intravenous autologous NK cell infusion+rhIL-15 | Solid tumors, brain tumors, sarcoma, pediatric cancers, neuroblastoma | Phase 1 | Safety | 94 | |
| NCT01727076 | Subcutaneous N-803 | Metastatic malignancies | Phase 1 | NK expansion | Injection skin rash | 95 |
| NTC01727076 | Intravenous N-803 | Metastatic malignancies | Phase 1 | NK expansion | Nausea, fatigue | 95 |
| NTC01885897 | Intravenous N-803 | Hematologic malignancies relapsing after allo-hematopoietic cell transplantation (HCT) | Phase 1 | Clearance of lung metastasis in two patients. Modest expansion of NK and CD8+T cells |
Fever chills and rigors | 96 |
| NCT01885897 | Subcutaneous H-803 | Hematologic malignancies relapsing after allo-HCT | Phase 1 | Sustained expansion of NK and CD8+T cells | Injection skin rash | 96 |
| NCT02523469 | Subcutaneous H-803+PD1 Blockade | Non-small-cell lung carcinoma | Phase 1b | Reinduction of response to PD-1 blockade | Injection skin rash | 100 |
HCT, allo-hematopoietic cell transplantation; NK, natural killer; RCC, renal clear carcinoma cell; rhIL-15, human recombinant interleukin-15.