Table 2.
Clinical Trials Involving IL-15-based Therapies.
| Clinical ID | Phase | Aim | Status | Study Period | Tumor Type | No of patients | Treatment | IL-15 Dose | Principle Investigator |
Responsible Party |
|---|---|---|---|---|---|---|---|---|---|---|
| NCT01021059 | I | Safety | Completed | 2009–2016 | Metastatic Melanoma and Metastatic Renal Cell Carcinoma | 18 | rhIL-15 (IV) | 0.3–25 mcg/kg/day for 12 days | T.A. Waldmann | NCI, MD |
| NCT01369888 | I | Safety/Efficacy | Terminated (autoimmune toxicity) | 2011–2014 | Metastatic Melanoma | 3 | CY + Fludarabine + TILs + rhIL-15 (IV) | 0.25–0.55 mcg/kg/day for 10 days | S.A. Rosenberg | NIH, MD |
| NCT01385423 | I | Safety/Efficacy | Completed | 2011–2015 | AML | 26 | Fludarabine + CY+ Haploidentical NK cell + rhIL-15 (IV) | 0.25–3 mcg/kg/day for 12 days | J.S. Miller | Masonic Cancer Center, MN |
| NCT01572493 | I | Safety | Recruiting | 2012–2018 | Lymphoma, Carcinoma | Estimated 52 | rhIL-15 (IV) | 0.1–8 mcg/kg/day for 10 days | K. C. Conlon | NCI, MD |
| NCT01727076 | I | Safety | Ongoing, | 2013–2016 | Advanced Melanoma, Renal Cell Cancer, Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Cancer | Estimated 30 | rhIL-15 (SC) | NA | J. S. Miller | NCI, MD |
| NCT01875601 | I | Safety | Completed | 2013–2015 | Solid Tumors, Brain Tumors, Sarcoma, Pediatric Cancers, Neuroblastoma | 16 | Autologous NK cell infusion + rhIL-15 (IV) | 0.25–0.75 mcg/kg/day for 10 days | M. S. Merchant | NCI, MD |
| NCT01885897 | I/II | Safety/Efficacy | Recruiting | 2013–2018 | AML, ALL, MDS, Lymphoma, Myeloma, CLL and CML | Estimated 61 | ALT-803 (IV) | 1–30 mcg/kg once a week for 4 weeks | J.S. Miller | Masonic Cancer Center, MN |
| NCT01946789 | I | Safety/Efficacy | Recruiting | 2014–2018 | Melanoma, Renal Cell, Non-Small Cell Lung Cancer, Squamous Cell Head and Neck Cancer | Estimated 20 | ALT-803 (IV) | NA | K. Margolin | Altor Bioscience, FL |
| NCT02138734 | I/II | Safety/Efficacy | Recruiting | 2014–2018 | Non-muscle Invasive Bladder Cancer | Estimated 81 | Intravesical BCG + ALT-803 (Intravesical) | NA | H. C. Wong | Altor Bioscience, FL |
| NCT02099539 | I/II | Safety/Efficacy | Recruiting | 2014–2020 | Relapsed or Refractory Multiple Myeloma | Estimated 57 | ALT-803 (IV) | NA | H. C. Wong | Altor Bioscience, FL |
| NCT02452268 | I | Safety/Efficacy | Recruiting | 2015–2018 | Skin Melanoma, Renal Cell Cancer, Non-Small Cell Lung Cancer and Head and Neck Squamous Cell Carcinoma | Estimated 42 | hetIL-15 (IL-15/sIL-15Rα) (SC) | NA | Not Provided | Novartis, Switzerland |
| NCT02395822 | II | Efficacy | Suspended Recruiting | 2015–2019 | AML | Estimated 24 | Fludarabine + CY + Haploidentical NK cells activated with 10 ng/mL of IL–15 + rhIL-15 (SC) | 2 mcg/kg once a day for 5 days, 2 day rest, 5 days on | J. S. Miller | Masonic Cancer Center, MN |
| NCT02384954 | I/II | Safety/Efficacy | Recruiting | 2015–2023 | B Cell Non-Hodgkin Lymphoma (NHL) | Estimated 86 | Rituximab + ALT-803 (IV) | NA | H. C. Wong | Altor Bioscience, FL |
| NCT02465957 | II | Safety/Efficacy | Recruiting | 2015–2017 | Merkel Cell Carcinoma (MCC) | Estimated 24 | Activated NK-92 Natural Killer (aNK) Cell Infusions + ALT-803 (SC) | 10 μg/kg on the first day of every aNK fusion | Not Provided | NantKwest, Inc., CA |
| NCT02523469 | I/II | Safety | Recruiting | 2016–2019 | Advanced or Metastatic Non-Small Cell Lung Cancer | Estimated 91 | ALT–803 + Nivolumab | 6–15 μg/kg | J. Wrangle | Medical University of South Carolina, SC/Altor Bioscience, FL |
| NCT02559674 | I/II | Safety/Efficacy | Recruiting | 2016–2022 | Advanced Pancreatic Cancer | Estimated 66 | Alt-803 (IV) + Gemcitabine (SC) + Nab-Paclitaxel (SC) | NA | H. C. Wong | Altor Bioscience, FL |
| NCT02689453 | I | Safety/Efficacy | Recruiting | 2016–2022 | Refractory or Relapsed Chronic and Acute ATL | Estimated 30 | Alemtuzumab + rhIL-15 (SC) | 1–3 mcg/kg/dose for 10 doses over two weeks | T.A. Waldmann | NCI, MD |
| NCT02752243 | I/II | Safety/Efficacy | Recruiting | 2016–2020 | Relapsed Acute Leukemia, MDS after SCT | Estimated 40 | IL-15 Activated Cytokine Induced Killer (CIK) Cells (IV) | NA | P. Bader | Johann Wolfgang Goethe University Hospital, Germany |
| NCT02989844 | II | Efficacy | Not yet recruiting | 2017–2022 | Prevent Relapse of AML and MDS after alloHCT | Estimated 60 | ALT-803 (SC) | 6 mcg/kg once a week (4 weeks on/4 weeks off) | C. Ustun | Masonic Cancer Center, MN |
| NCT03003728 | II | Efficacy | Not yet recruiting | 2017–2018 | High-Risk Multiple Myeloma Post-Autologous Stem Cell Transplant (ASCT) | Estimated 10 | Elotuzumab + Melphalan + Expanded NK Cells + ALT-803 (SC) | 10 μg/kg on days 1, 8, 15, and 22 | F. van Rhee | University of Arkansas, AR |
| NCT02890758 | I | Safety/Efficacy | Not yet recruiting | 2017–2019 | AML, MDS, ALL, CML, CLL, NHL, Myeloproliferative Syndromes, Plasma Cell Myeloma, Colon/Rectal Carcinoma and Soft Tissue Sarcomas | Estimated 54 | NK Cells (IV) + ALT-803 (IV) | 6 mcg/kg weekly for 4 weeks | D. Wald | Case Comprehensive Cancer Center, OH |
| NCT03022825 | II/III | Safety/Efficacy | Not yet recruiting | 2017–2020 | Unresponsive High Grade Non-muscle Invasive Bladder Cancer | Estimated 80 | Intravesical BCG + ALT-803 | NA | K. Chamie | Altor Bioscience, FL |
| NCT03054909 | I | Safety/Efficacy | Not yet recruiting | 2017–2020 | Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer | Estimated 28 | ALT-803 (SC and IP) | 10 mcg/kg weekly (4 weeks on/4 weeks off)-4 courses | M. Geller | Masonic Cancer Center, MN |