Evaluation of the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.

NCT07692607 | Completed

• 1 other identifier: LB-AT-CIK-AS-AD-CR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• What adverse events occur within 2 years following CIK infusion?
• Does viral reactivation (CMV, EBV, BKV) occur and lead to infection during the early transplant period of autologous hematopoietic stem cell transplant after CIK infusion? Patients will:
• Receive a single infusion of CIK at a dose of 1x10\^9 to 1x10\^10 cells either intravenously or using a central venous catheter within 14±4 days after receiving the autologous hematopoietic stem cell transplantation.
• Attend follow-up visits at the clinic for 24 months after the infusion.

Conditions

Autologous Hematopoietic Stem Cell Transplant

Keywords

Cytokine-Induced Killer Cells; Hematopoietic Stem Cell Transplantation; Lymphoma; Minimal Residual Disease; CMV; EBV; BKV; Viral infections

Outcome Measures

Primary Outcomes (2)

• 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

  * Progression-free survival (PFS) time is defined as the period from the date of autologous hematopoietic transplantation to the date of event. * An event is defined as disease progression or death due to any cause. * The censoring date is defined as the last date on which it was confirmed that no event had occurred. In cases of loss to follow-up, the censoring date is set as the last date on which the patient was confirmed to be alive.

  From the screening visit through 24 months after treatment initiation.

Secondary Outcomes (3)

• 2-Year Overall Survival (OS) Ratio

  From the screening visit through 24 months after treatment initiation.

• Immunological Assessment and Immune Reconstitution

  From the screening visit through 24 months after treatment initiation.

• Viral Reconstitution

  From the screening visit through 24 months after treatment initiation.

Study Arms (1)

CIK cells

EXPERIMENTAL

Biological: CIK cells

Interventions

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.

CIK cells

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following criteria:
• Patients aged 19 to 70 years.
• Patients with lymphoma who are expected to undergo autologous hematopoietic stem cell transplantation.
• Patients with the ECOG performance status scale of 0 or 1.
• Patients with a life expectancy longer than 3 months.
• Patients without evidence of an acute infectious disease.
• Patients without evidence of a concomitant malignancy.
• Individuals who have provided written consent to comply with the restrictions, either by themselves or through their legal guardians.

You may not qualify if:

• Female patients who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods.
• Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection.
• Patients aged below 19 years or above 70 years.
• Patients with the ECOG performance status scale of 2, 3, or 4.
• Patients who have been diagnosed with HIV, uncontrollable hypertension, unstable angina, congestive heart failure (NY class II or higher), uncontrollable severe diabetes, coronary angioplasty within the past 6 months, acute myocardial infarction or non-malignant disease, including uncontrollable atrial or ventricular fibrillation, within the past 6 months.
• Patients with mental illness or drug intoxication that may affect the results of this clinical study.
• Patients who are participating in another clinical study.
• Patients deemed ineligible for participation in this clinical study by the investigator.
• Patients with other severe medical conditions that may compromise compliance with the clinical study.

Sponsors & Collaborators

• LucasBio: lead

Study Sites (1)

The Catholic University of Korea Seoul St.Mary's Hospital

Seoul, 06591, South Korea

Location

Related Publications (15)

• 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.

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• 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.

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• 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.

  PMID: 26768688 BACKGROUND

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  PMID: 28712935 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.

  PMID: 30878607 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.

  PMID: 19294626 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.

  PMID: 15744236 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.

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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 22500889 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.

  PMID: 25196601 BACKGROUND

• 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.

  PMID: 41520915 RESULT

MeSH Terms

Conditions

Lymphoma; Neoplasm, Residual; Virus Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections

Study Officials

• Seok-Goo Cho, MD-PhD

  Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Hematology

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 9, 2026
• Study Start: March 28, 2022
• Primary Completion: February 11, 2025
• Study Completion: March 17, 2026
• Last Updated: July 9, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)