Table 1.
Completed allogeneic NK cell clinical trials.
| NCT Number | Title | NK Cell source | Status | Conditions | Interventions | Clinical trial phase | Population | Sponsor/ Collaborators | Dates | Locations / Outcome | |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT03358849 | Phase 1 Clinical Trial to Evaluate the Safety of Allogeneic NK Cell ("SMT-NK") Cell Therapy in Advanced Biliary Tract Cancer | Not available | Completed: No results posted | • Advanced Biliary Tract Cancer | • Biological: Natural killer cell | Study Type: Interventional Phase: Phase 1 |
Enrollment: 9 Age: 18 Years to 75 Years (Adult, Older Adult) Sex: All |
• Yonsei University | Study Start: October 17, 2017 rimary Completion: September 27, 2018 Last Update Posted: January 16, 2019 |
• Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea, Republic of |
| 2 | NCT02008929 | to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell) | Allogeneic expanded NK Cells | Completed: No results posted | • Hepatocellular Carcinoma | • Biological: MG4101 | Study Type: Interventional Phase: Phase 2 |
Enrollment: 5 Age: 20 Years to 69 Years (Adult, Older Adult) Sex: All |
• Samsung Medical Center | Study Start: August 2014 Last Update Posted: December 3, 2015 |
• Samsung Medical Center, Seoul, Korea, Republic of |
| 3 | NCT01212341 | Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor | Allogeneic NK Cells | Completed - No results posted | • Malignant Lymphomas • Solid Tumors |
• Biological: Allogeneic NK cells | Study Type: Interventional Phase: Phase 1 |
Enrollment: 18 Age: 18 Years and older (Adult, Older Adult) Sex: All |
• Seoul National University Hospital • Green Cross Corporation | Study Start: September 2010 Primary Completion: August 2012 Last Update Posted: August 19, 2013 |
• Seoul National University Hospital, Seoul, Korea, Republic of |
| 4 | NCT00383994 | Immunotherapy With NK Cell, Rituximab and Rhu-GMCSF in Non-Myeloablative Allogeneic Stem Cell Transplantation | Blood derived NK Cells | Completed No resultrs posted | • Lymphoma • Leukemia • Transplantation, Stem Cell • Lymphoid Malignancies • Disorder Related to Transplantation |
• Drug: GM-CSF • Drug: Rituximab • Biological: NK Cell Infusion |
Study Type: Interventional Phase: Phase 1 |
Enrollment: 6 Age: Child, Adult, Older Adult Sex: All |
• M.D. Anderson Cancer Center • Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma | Study Start: September 2006 Primary Completion: July 22, 2019 Last Update Posted: July 31, 2019 |
• University of Texas MD Anderson Cancer Center, Houston, Texas, United States |
| 5 | NCT00402558 | Alloreactive NK Cells for Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS) | Completed - no results posted | Completed No results posted | • Myelodysplastic Syndrome • Leukemia |
• Drug: Thymoglobulin • Drug: Busulfan • Drug: Fludarabine • Procedure: Alloreactive NK Infusion • Drug: G-CSF • Drug: Tacrolimus • Drug: Methotrexate • Drug: Interleukin-2 |
Study Type: Interventional Phase: Phase 1 |
Enrollment: 15 Age: up to 70 Years (Child, Adult, Older Adult) Sex: All |
• M.D. Anderson Cancer Center | Study Start: May 2006 Primary Completion: April 2014 Last Update Posted: May 8, 2015 |
• UT MD Anderson Cancer Center, Houston, Texas, United States |
| 6 | NCT01853358 | Phase I of Infusion of Selected Donor NK Cells After Allogeneic Stem Cell Transplantation | HLA identical allogeneic NK Cells | Completed-Phase 1-No results posted | • Hematological Malignancy | • Biological: NK Cell infusion | Study Type: Interventional Phase: Phase 1 |
Enrollment: 17 Age: 18 Years to 70 Years (Adult, Older Adult) Sex: All |
• Institut Paoli- Calmettes | Study Start: April 2013 Primary Completion: March 15, 2018 Last Update Posted: July 12, 2018 |
• Institut Paoli-Calmettes, Marseille, France |
| 7 | NCT01287104 | A Phase I Study of NK Cell Infusion Following Allogeneic Peripheral Blood Stem Cell Transplantation From Related or Matched Unrelated Donors in Pediatric Patients With Solid Tumors and Leukemias | Allogeneic Bone marrow NK Cells | Completed - Has results | • Leukemia • Lymphoma |
• Biological: Natural Killer (NK) Cell Infusion • Biological: Stem Cell Infusion - Pag |
Study Type: Interventional Phase: Phase 1 |
Age: 4 Years to 35 Years (Child, Adult) Sex: All |
• National Cancer Institute (NCI) • National Institutes of Health Clinical Center (CC) |
Study Start: January 29, 2011 Primary Completion: June 28, 2018 Last Update Posted: August 22, 2019 |
• National Institutes of Health Clinical Center, Five of 9 transplant recipients experienced acute graft-versus-host disease (GVHD) following aNK-DLI, with grade 4 GVHD observed in 3 subjects. |
| 8 | NCT02716571 | Recruiting Blood Donor With Allogeneic Natural Killer Cell | Allogeneic natural killer cell | Completed: No results posted | • Healthy Volunteers | • Other: Leukapheresis or Plasmapheresis | Study Type: Interventional Phase: Not Applicable |
Enrollment: 90 Age: 20 Years to 60 Years (Adult) Sex: All |
• Seoul National University Hospital | Study Start: March 28, 2016 Primary Completion: June 2, 2017 Last Update Posted: July 31, 2017 |
• Seoul National University Hospital, Seoul, Korea, Republic of |
| 9 | NCT00877110 | Anti-GD2 3F8 Antibody and Allogeneic Natural Killer Cells for High-Risk Neuroblastoma | Allogeneic NK Cells from a family member who shares half of the HLA proteins | Completed: No results posted | • Neuroblastoma • Bone Marrow, Sympathetic Nervous System |
• Drug: cyclophosphamide, vincristine, topotecan ,allogenei NK cells & 3F8 | Study Type: Interventional Phase: Phase 1 |
Enrollment: 71 Age: Child, Adult, Older Adult Sex: All |
• Memorial Sloan Kettering Cancer Center | Study Start: April 2, 2009 Primary Completion: January 7, 2019 Last Update Posted: January 10, 2019 |
• Memorial Sloan Kettering Cancer Center, New York, New York, United States |
| 10 | NCT02301065 | Analysis of T Cell and Natural Killer (NK) Cell in Relation to Viral Infections in Pediatric Stem Cell Transplant Patients and Donors | Blood derived FcRg-CD56+CD3- NK cells in pediatric allogeneic HSCT patients and healthy donors | Completed: No results posted | • Hematologic Malignancies | Study Type: Observational Phase: | Enrollment: 35 Age: up to 21 Years (Child, Adult) Sex: All |
• St. Jude Children's Research Hospital • Michigan State University | Study Start: October 13, 2016 Primary Completion: February 6, 2017 Last Update Posted: July 17, 2017 |
• St. Jude Children's Research Hospital, Memphis, Tennessee, United States | |
| 11 | NCT02845999 | Allogenic Immunotherapy Based on Natural Killer (NK) Cell Adoptive Transfer in Metastatic Gastrointestinal Carcinoma Treated With Cetuximab | Haploidentical Natural Killer (NK) cells | Completed-No Results posted | • Gastrointestinal Metastatic Cancer | • Biological: allogenic immunotherapy based on Natural Killer cells adoptive transfer • Biological: cetuximab • Drug: Cyclophosphamide • Drug: fludarabine • Drug: interleukin-2 |
Study Type: Interventional Phase: Phase 1 | Enrollment: 9 Age: 18 Years to 65 Years (Adult, Older Adult) Sex: All |
• Centre Hospitalier Universitaire de Besancon • National Cancer Institute, France |
Study Start: November 2009 Primary Completion: January 2013 Last Update Posted: July 27, 2016 |
• University hospital of Besançon, Besançon, France |
| 13 | NCT01181258 | Penostatin, Rituximab and Ontak and Allogeneic Natural Killer (NK) Cells for Refractory Lymphoid Malignancies | Interleukin 2-activated Allogeneic Natural Killer Cells | Completed-Has results | • Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia |
• Drug: Rituximab • Biological: Interleukin-2 • Biological: Natural killer cells • Drug: Cyclophosphamide • Drug: Methylprednisolone • Drug: Fludarabine |
Study Type: Interventional Phase: Phase 2 | Enrollment: 16 Age: Child, Adult, Older Adult Sex: All |
• Masonic Cancer Center, University of Minnesota | Study Start: August 2010 Primary Completion: September 2015Study Completion: July 2016 First Posted: August 13, 2010 Results First Posted: May 18, 2017 Last Update Posted: February 6, 2018 |
• Masonic Cancer Center, University of Minnesota, Observations support development of donor NK cellular therapies for advanced NHL as a strategy to overcome chemoresistance |
| 14 | NCT01105650 | Allogeneic Natural Killer (NK) Cells for Ovarian, Fallopian Tube, Peritoneal and Metastatic Breast Cancer | Allogeneic donor cells | Completed-Has results | • Ovarian Cancer • Fallopian Tube Cancer • Primary Peritoneal Cancer • Breast Cancer |
• Drug: Fludarabine • Drug: Cyclophosphamide • Drug: Cyclosporine • Biological: Natural killer cells • Drug: IL-2 • Drug: Methylprednisolone • Drug: Interleukin-2 |
Study Type: Interventional Phase: Phase 2 | Enrollment: 13 Age: 18 Years and older (Adult, Older Adult) Sex: Female |
• Masonic Cancer Center, University of Minnesota | Study Start: July 2010 Primary Completion: April 2014 Last Update Posted: December 28, 2017 |
• Masonic Cancer Center, University of Minnesota, Some adverse events reported - not published |
| 15 | NCT00586703 | Safety Trial of NK Cell DLI 3-5/6 Family Member Following Nonmyeloablative ASCT | CD56-NK cells from mismatched donors | Completed-Has results | • Lymphoma | • Device: NK-CD56 | Study Type: Interventional Phase: Phase 1 |
Enrollment: 21 Age: 18 Years and older (Adult, Older Adult) Sex: All |
• David Rizzieri, MD • Duke University | Study Start: April 2005 Primary Completion: April 2013 Last Update Posted: June 12, 2014 |
• Duke University Health Systems" A 1-step, high-yield process is feasible, and results in high doses of NK cells infused with little toxicity. NK cell-enriched DLIs result in improved immune recovery and outcomes for some |
| 16 | NCT02118285 | Intraperitoneal Natural Killer Cells and INCB024360 for Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancer | haploidentical donor NK cells and IL-2 | Completed-No results posted | • Ovarian Cancer • Fallopian Tube Carcinoma • Primary Peritoneal Carcinoma |
• Drug: Fludarabine • Drug: Cyclophosphamide • Biological: NK cells • Biological: IL-2 • Drug: INCB024360 |
Study Type: Interventional Phase: Phase 1 |
Enrollment: 2 Age: 8 Years and older (Adult, Older Adult) Sex: Female |
• Masonic Cancer Center, University of Minnesota • Incyte Corporation | Study Start: July 28, 2014 Last Update Posted: December 5, 2017 |
• University of Minnesota Masonic Cancer Center, Minneapolis, Minnesota, United States |
| 18 | NCT00526292 | Chemotherapy and a Donor Natural Killer Cell Infusion in Treating Patients With Relapsed or Persistent Leukemia or Myelodysplastic Syndrome After a Donor Stem Cell Transplant | Allogeneic NK Cells from a family member who shares half of the HLA proteins | Completed:-Has results | • Leukemia • Myelodysplastic Syndromes |
• Biological: natural killer cell therapy • Drug: cyclophosphamide • Drug: fludarabine |
Study Type: Interventional Phase: Phase 2 |
Enrollment: 12 Age: up to 120 Years (Child, Adult, Older Adult) Sex: All |
• Memorial Sloan Kettering Cancer Center • National Cancer Institute (NCI) |
Study Start: August 2007 Primary Completion: July 2015 Last Update Posted: February 12, 2016 |
• Memorial Sloan Kettering Cancer Center, New Yor: Results not conclusive as 4/6 patients showed some adverse events |
| 19 | NCT02854839 | A Study of MG4101 (Allogeneic Natural Killer Cell) for Intermediate-stage of Hepatocellular Carcinoma | allogeneic Natural killer cells | Completed No results posted | • Hepatocellular Carcinoma | • Biological: MG4101 | Study Type: Interventional Phase: Phase 2 |
Enrollment: 78 Age: 18 Years to 80 Years (Adult, Older Adult) Sex: All |
• Green Cross LabCell Corporation | Study Start: November 28, 2016 Primary Completion: September 27, 2018 Last Update Posted: September 26, 2019 |
• Seoul National University Hospital, Seoul, Korea, Republic of • Seoul Asan Medical center, Seoul, Korea, Republic of • Samsung Medical Center, Seoul, Korea, Republic of and others |
| 20 | NCT01386619 | NK DLI in Patients After Human Leukocyte Antigen (HLA)- Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) | HLA haploidentical -CD3-depleted/CD56+ selected natural killer cells collected from apheresis products | Completed No results posted | • Leukemia, Myeloid, Acute • Precursor Cell Lymphoblastic Leukemia- Lymphoma • Myelodysplastic Syndromes • Lymphoma • Neuroblastoma • Rhabdomyosarcoma |
• Biological: CD3- depleted/CD56+ selected natural killer cells collected from apheresis products | Study Type: Interventional Phase: • Phase 1 • Phase 2 |
Enrollment: 15 Age: Child, Adult, Older Adult Sex: All |
• University Hospital, Basel, Switzerland | Study Start: January 2004 Primary Completion: March 2011 Last Update Posted: September 15, 2015 |
• Universitätsklinikum, Frankfurt, Germany • University Hospital, Basel, Switzerland |
| 21 | NCT00274846 | Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia | Peripheral Blood derived NK cells and also stem cells from the same allogeneic donor | Completed Has Results | • Leukemia | • Biological: aldesleukin • Biological: therapeutic allogeneic lymphocytes • Drug: cyclophosphamide • Drug: fludarabine phosphate • Procedure: in vitro treated peripheral blood stem cell transplantation |
Study Type: Interventional Phase: Phase 2 |
Enrollment: 21 Age: 2 Years and older (Child, Adult, Older Adult) Sex: All |
• Masonic Cancer Center, University of Minnesota | Study Start: March 2005 Primary Completion: June 2008 Last Update Posted: December 28, 2017 |
• Masonic Cancer Center, Minneapolis, : Supports the need to optimize the in vivo cytokine milieu where adoptively transferred NK cells compete with other lymphocytes to improve clinical efficacy in patients with refractory AML |