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The goal of this clinical study is to evaluate the safety of cytokine-induced-killer (CIK) cells during early transplant period of autologous hematopoietic stem cell transplant. The main questions it aims to answer are:
Patients will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CIK cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CIK cells | Biological | Derived from the patient (autologous) prior to autologous hematopoietic stem cell transplantation and administered intravenously as fresh cells at a dose of 1x10^9 to 1x10^10 cells over 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Event Assessment | Adverse events, including any unintended signs, symptoms, or newly developed or worsened diseases, occurring after CIK infusion are tracked for 2 years after the treatment initiation. | From the baseline visit through 24 months after treatment initiation. |
| 2-Year Progression-Free Survival (PFS) Ratio |
| From the screening visit through 24 months after treatment initiation. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Year Overall Survival (OS) Ratio |
|
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Inclusion Criteria:
Patients who meet all of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Seok-Goo Cho, MD-PhD | Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Catholic University of Korea Seoul St.Mary's Hospital | Seoul | 06591 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21986635 | Background | Linn YC, Niam M, Chu S, Choong A, Yong HX, Heng KK, Hwang W, Loh Y, Goh YT, Suck G, Chan M, Koh M. The anti-tumour activity of allogeneic cytokine-induced killer cells in patients who relapse after allogeneic transplant for haematological malignancies. Bone Marrow Transplant. 2012 Jul;47(7):957-66. doi: 10.1038/bmt.2011.202. Epub 2011 Oct 10. | |
| 21664472 |
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| From the screening visit through 24 months after treatment initiation. |
| Immunological Assessment and Immune Reconstitution | T cell reconstitution before and after the CIK infusion is assessed using flow cytometry and cytokine expression assays. | From the screening visit through 24 months after treatment initiation. |
| Viral Reconstitution | CMV, EBV, and BKV reactivation, along with infection-related complications, are assessed to evaluate the safety and efficacy of the CIK cells. | From the screening visit through 24 months after treatment initiation. |
| Laport GG, Sheehan K, Baker J, Armstrong R, Wong RM, Lowsky R, Johnston LJ, Shizuru JA, Miklos D, Arai S, Benjamin JE, Weng WK, Negrin RS. Adoptive immunotherapy with cytokine-induced killer cells for patients with relapsed hematologic malignancies after allogeneic hematopoietic cell transplantation. Biol Blood Marrow Transplant. 2011 Nov;17(11):1679-87. doi: 10.1016/j.bbmt.2011.05.012. Epub 2011 May 25. |
| 17606446 | Background | Introna M, Borleri G, Conti E, Franceschetti M, Barbui AM, Broady R, Dander E, Gaipa G, D'Amico G, Biagi E, Parma M, Pogliani EM, Spinelli O, Baronciani D, Grassi A, Golay J, Barbui T, Biondi A, Rambaldi A. Repeated infusions of donor-derived cytokine-induced killer cells in patients relapsing after allogeneic stem cell transplantation: a phase I study. Haematologica. 2007 Jul;92(7):952-9. doi: 10.3324/haematol.11132. |
| 26768688 | Background | Rettinger E, Huenecke S, Bonig H, Merker M, Jarisch A, Soerensen J, Willasch A, Bug G, Schulz A, Klingebiel T, Bader P. Interleukin-15-activated cytokine-induced killer cells may sustain remission in leukemia patients after allogeneic stem cell transplantation: feasibility, safety and first insights on efficacy. Haematologica. 2016 Apr;101(4):e153-6. doi: 10.3324/haematol.2015.138016. Epub 2016 Jan 14. No abstract available. |
| 28712935 | Background | Introna M, Lussana F, Algarotti A, Gotti E, Valgardsdottir R, Mico C, Grassi A, Pavoni C, Ferrari ML, Delaini F, Todisco E, Cavattoni I, Deola S, Biagi E, Balduzzi A, Rovelli A, Parma M, Napolitano S, Sgroi G, Marrocco E, Perseghin P, Belotti D, Cabiati B, Gaipa G, Golay J, Biondi A, Rambaldi A. Phase II Study of Sequential Infusion of Donor Lymphocyte Infusion and Cytokine-Induced Killer Cells for Patients Relapsed after Allogeneic Hematopoietic Stem Cell Transplantation. Biol Blood Marrow Transplant. 2017 Dec;23(12):2070-2078. doi: 10.1016/j.bbmt.2017.07.005. Epub 2017 Jul 13. |
| 30878607 | Background | Merker M, Salzmann-Manrique E, Katzki V, Huenecke S, Bremm M, Bakhtiar S, Willasch A, Jarisch A, Soerensen J, Schulz A, Meisel R, Bug G, Bonig H, Klingebiel T, Bader P, Rettinger E. Clearance of Hematologic Malignancies by Allogeneic Cytokine-Induced Killer Cell or Donor Lymphocyte Infusions. Biol Blood Marrow Transplant. 2019 Jul;25(7):1281-1292. doi: 10.1016/j.bbmt.2019.03.004. Epub 2019 Mar 13. |
| 19294626 | Background | Olioso P, Giancola R, Di Riti M, Contento A, Accorsi P, Iacone A. Immunotherapy with cytokine induced killer cells in solid and hematopoietic tumours: a pilot clinical trial. Hematol Oncol. 2009 Sep;27(3):130-9. doi: 10.1002/hon.886. |
| 15744236 | Background | Leemhuis T, Wells S, Scheffold C, Edinger M, Negrin RS. A phase I trial of autologous cytokine-induced killer cells for the treatment of relapsed Hodgkin disease and non-Hodgkin lymphoma. Biol Blood Marrow Transplant. 2005 Mar;11(3):181-7. doi: 10.1016/j.bbmt.2004.11.019. |
| 10576658 | Background | Schmidt-Wolf IG, Finke S, Trojaneck B, Denkena A, Lefterova P, Schwella N, Heuft HG, Prange G, Korte M, Takeya M, Dorbic T, Neubauer A, Wittig B, Huhn D. Phase I clinical study applying autologous immunological effector cells transfected with the interleukin-2 gene in patients with metastatic renal cancer, colorectal cancer and lymphoma. Br J Cancer. 1999 Nov;81(6):1009-16. doi: 10.1038/sj.bjc.6690800. |
| 25890480 | Background | Cui J, Li L, Wang C, Jin H, Yao C, Wang Y, Li D, Tian H, Niu C, Wang G, Han W, Xu J, Chen J, Li W. Combined cellular immunotherapy and chemotherapy improves clinical outcome in patients with gastric carcinoma. Cytotherapy. 2015 Jul;17(7):979-88. doi: 10.1016/j.jcyt.2015.03.605. Epub 2015 Apr 15. |
| 32484595 | Background | Zhang Y, Schmidt-Wolf IGH. Ten-year update of the international registry on cytokine-induced killer cells in cancer immunotherapy. J Cell Physiol. 2020 Dec;235(12):9291-9303. doi: 10.1002/jcp.29827. Epub 2020 Jun 2. |
| 28679475 | Background | Introna M. CIK as therapeutic agents against tumors. J Autoimmun. 2017 Dec;85:32-44. doi: 10.1016/j.jaut.2017.06.008. Epub 2017 Jul 2. |
| 22500889 | Background | Mesiano G, Todorovic M, Gammaitoni L, Leuci V, Giraudo Diego L, Carnevale-Schianca F, Fagioli F, Piacibello W, Aglietta M, Sangiolo D. Cytokine-induced killer (CIK) cells as feasible and effective adoptive immunotherapy for the treatment of solid tumors. Expert Opin Biol Ther. 2012 Jun;12(6):673-84. doi: 10.1517/14712598.2012.675323. Epub 2012 Apr 14. |
| 25196601 | Background | Schmeel FC, Schmeel LC, Gast SM, Schmidt-Wolf IG. Adoptive immunotherapy strategies with cytokine-induced killer (CIK) cells in the treatment of hematological malignancies. Int J Mol Sci. 2014 Aug 21;15(8):14632-48. doi: 10.3390/ijms150814632. |
| 41520915 | Result | Min GJ, Kim N, Im KI, Lee J, Kim T, Kim DJ, Cho SG. Cytokine-Induced Killer Cell Therapy as a Postremission Strategy in High-Risk Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation: A Prospective Investigator-Initiated Clinical Study. Transplant Cell Ther. 2026 Apr;32(4):448.e1-448.e16. doi: 10.1016/j.jtct.2026.01.001. Epub 2026 Jan 9. |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D018365 | Neoplasm, Residual |
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007239 | Infections |
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