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. 2013 Apr 22;10(3):230–252. doi: 10.1038/cmi.2013.10

Table 3. Clinical trials of tumor immunotherapy by using NK cells.

Source of NK cells Stage Subjects Treatment Styles Effects Status Country Reference/ClinicalTrials.gov Identifier
Autologous NK cells (from PBMC) Phase I 11 metastatic colorectal cancer; 1 NSCLC (0.001–0.3)×109 cells/dose; i.v. 1–4 doses/cycle, 1–6 cycle Used alone No toxicities Completed Germany [175]
  Phase I 7 metastatic melanoma; 1 metastatic renal cell carcinoma (4.70±2.10)×1010 cells; i.v. Combined with chemotherapy No toxicities Completed United States [176]
  Phase I Metastatic nasopharyngeal i.v. Used alone — Completed Singapore NCT00717184
  Phase I Metastatic cancers; hematological malignancies i.v. Used alone — Recruiting participants United States NCT00720785
  Phase I Breast cancer, glioma, hepatocellular cancer, squamous cell lung cancer, pancreatic cancer, colon cancer, prostate cancer i.v. Used alone — Suspended United States NCT00909558
Allogeneic NK cells (from PBMC) Phase I 15 advanced NSCLC (0.2–29)×106 cells/kg/dose; i.v. 2–4 doses Combined with chemotherapy No side effects;clinically effective Completed Greece [196]
  Phase I Acute myeloid leukemia i.v. Combined with chemotherapy — Ongoing United States NCT00187096
  Phase I Lymphoma; leukemia; stem cell transplantation i.v. Combined with Rituximab — Completed United States NCT00383994
  Phase I Lymphoma 1×107 cells/kg; i.v. Combined with SCT No toxicities Ongoing United States NCT00586690; NCT00586703;[178]
  Phase I Non-B lineage hematological malignancies and solid tumors i.v. Combined with chemotherapy — Recruiting participants United States NCT00640796
  Phase I Lymphoma; myeloma; leukemia i.v. Used alone — completed United States NCT00660166
  Phase I ALL; CML; JMML; MDS; NHL i.v. Combined with chemotherapy and immunotherapy — Recruiting participants United States NCT00697671
  Phase I 13 acute myeloid leukemia (1–5)×106 cells/kg; i.v. Combined with chemotherapy No toxicity including GVHD Unknown Italy NCT00799799; [177]
  Phase I Neuroblastoma i.v. Combined with chemotherapy — Recruiting participants United States NCT00877110
  Phase I Acute lymphoblastic leukemia i.v Used alone — Recruiting participants United States NCT00995137
  Phase I Malignant lymphomas; solid tumors Singe-dose infusion:Cohort1: 1×106 cells/kg Cohort2: 1×107 cells/kg;Repeated dose infusion:Cohort3: 1×106 cells/kg; Cohort4: 3×106 cells/kg; Cohort5: 1×107 cells/kg; Cohort6: 3×107 cells/kg; i.v Used alone — Recruiting participants. Korea NCT01212341
  Phase I Leukemia, lymphoma, neuroblastoma, sarcoma, desmoplastic small round cell tumor 3 dose levels (1×105, 1×106, and 1×107 cells/kg); i.v Combined with chemotherapy — Recruiting participants. United States NCT01287104
  Phase I Acute myeloid leukemia Four cohorts of escalating doses receiving 0, 1, 10, or 20×106 NK cells/kg; i.v Combined with chemotherapy and immunotherapy — Recruiting participants United States NCT01478074
  Phase I Neuroblastoma minimum of 0.1×106 cells/kg; maximum of 400×106 CD45+ cells/kg, given once; i.v Combined with chemotherapy and immunotherapy — Recruiting participants United States NCT01576692
  Phase I LeukemiaChronic lymphocytic leukemia (3–7)×108 cells; however, if the dose of 3×108 cells is not achieved, all available NK cells will be infused; i.v. Combined with chemotherapy — Not yet open for participant recruitment United States NCT01619761
  Phase I/II Acute myelogenous leukemia (2–3)×107 cells/kg; i.v. Combined with chemotherapy — Ongoing participants United States NCT00303667
  Phase I/II LeukemiaLymphoma (1.5–8)×107 NK cells/kg; i.v. Combined with chemotherapy and immunotherapy — terminated United States NCT00625729
  Phase I/II Brain and central nervous system tumors; chronic myeloproliferative disorders; leukemia; lymphoma; lymphoproliferative disorder; multiple myeloma and plasma cell neoplasm; myelodysplastic syndromes; myelodysplastic/myeloproliferative neoplasms i.v. Combined with SCT — Recruiting participants Korea NCT00823524
  Phase I/II Melanoma i.v. Combined with chemotherapy — Completed Korea NCT00846833
  Phase I/II Multiple myeloma 3 dose levels (1.5×106 cells/kg, 1.5×107 cells/kg and 1×108 cells/kg), if safe, continuing with maximally 7 doses of 1×108 cells/kg; i.v. Combined with chemotherapy and SCT — Recruiting participants Switzerland NCT01040026
  Phase I/II Acute myeloid leukemia; advanced hematological malignancies; indication for allogeneic stem cell transplantation 1×107 cells/kg; i.v. Combined with chemotherapy and radiation therapy and SCT — Recruiting participants Germany NCT01220544
  Phase I/II Childhood solid tumor i.v. Used alone — Recruiting participants Spain NCT01337544
  Phase I/II Acute myeloid leukemia; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic syndromes; lymphoma; neuroblastoma; rhabdomyosarcoma ≥1×107 NK cells/kg; i.v. Combined with HLA-haploidentical HSCT — ongoing Switzerland NCT01386619
  Phase I/II Acute myeloid leukemia 1×106 NK cells/kg or 3×106 cells/kg; i.v. Used alone — Not yet open for participant recruitment United States NCT01520558
Allogeneic NK cells (from PBMC) Phase II 14 ovarian cancer; 6 breast cancer (8.33–39.41)×106 NK cells/kg; i.v. Combined with chemotherapy PR (4 patients); SD (12 patients); PD (3 patients) Completed United States [201]
  Phase II Acute lymphoblastic leukemia; lymphoma, lymphoblastic i.v. Combined with chemotherapy and SCT — Recruiting participants United States NCT00186875
  Phase II Metastatic melanoma; metastatic kidney cancer i.v. Combined with chemotherapy — Completed United States NCT00328861
  Phase II Breast cancer (1.5–8.0)×107 NK cells/kg; i.v. Combined with chemotherapy and radiation therapy — Terminated United States NCT00376805
  Phase II Leukemia; myelodysplastic syndromes i.v. Combined with chemotherapy — Recruiting participants. United States NCT00526292
  Phase II Fallopian tube cancer; ovarian cancer; peritoneal cavity cancer (1.5–8.0)×107 NK cells/kg; i.v. Combined with chemotherapy and radiation therapy — Terminated. United States NCT00652899
  Phase II Neuroblastoma i.v. Combined with chemotherapy and SCT — Terminated United States NCT00698009
  Phase II Leukemia; pediatric cancer i.v. Combined with chemotherapy — Completed United States NCT00941928
  Phase II Ovarian cancer; fallopian tube cancer; primary peritoneal cancer; breast cancer 8.0×107 cells/kg; i.v. Combined with chemotherapy — Recruiting participants United States NCT01105650
  Phase II Acute myelogenous leukemia ≤8.0×107 nucleated cells//kg; i.v. combined with chemotherapy — Ongoing United States NCT01106950
  Phase II Relapsed lymphoma; B cell non-Hodgkins lymphoma; refractory lymphoma; high risk chronic lymphocytic leukemia (1.5–8.0)×107 cells/kg; i.v. Combined with chemotherapy — Recruiting participants United States NCT01181258
  Phase II Acute myeloid leukemia; myelodysplastic syndrome i.v. Combined with SCT — Recruiting participants United States NCT01370213
  Phase II Leukemia; chronic myelogenous leukemia i.v. Combined with chemotherapy — Recruiting participants United States NCT01390402
  Phase II Myelodysplastic syndrome i.v. Combined with chemotherapy — Not yet open for participant recruitment United States NCT01593670
  Phase II Acute myelogenous leukemia i.v. Combined with chemotherapy — Not yet open for participant recruitment United States NCT01639456
NK-92 cells Phase I 11 advanced renal cell cancer; 1 melanoma 1×108 or 3×108 or 1×109 or 3×109 NK-92 cells/m2 body surface; i.v. three doses (3 patients/group) Used alone No severe hemodynamic or hematologic toxicities — United States [171]
  Phase I Acute myeloid leukemia 1×109 or 3×109 or 5×109 NK-92 cells/m2 body surface;i.v. two doses Used alone Status: suspended — United States NCT00900809
  Phase I Leukemia; lymphoma; myeloma; Hodgkin's disease 1×109 or 3×109 or 5×109 NK-92 cells/m2 body surface;i.v. on days 1, 3, and 5 of each cycle; 6 cycles monthly Used alone Status: suspended — Canada NCT00990717
  Phase I/II 4 sarcoma; 2 medulloblastoma; 1 PNET; 1 B-cell ALL (1–3)×109 NK-92 cells/m2 body surface; i.v. two doses Used alone Without any significant side effects;no conclusions as to the efficacy can be drawn   Germany [131]
NK cells from UCB Phase II Leukemia; myelodysplastic syndromes i.v. Combined with chemotherapy and SCT — Terminated United States NCT00354172

Abbreviations: ALL: Acute Lymphoblastic Leukemia; CML: Chronic Myelogenous Leukemia; JMML: Juvenile Myelomonocytic Leukemia; MDS: Myelodysplastic Syndrome; NHL: Non-Hodgkin's Lymphoma; NK, natural killer; PBMC, peripheral blood mononuclear cell; UCB, umbilical cord blood.