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Autologous Hematopoietic Stem Cell TransplantNCT07692607

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

A study testing CIK cells in people with Autologous Hematopoietic Stem Cell Transplant, run by LucasBio at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 19 to 70 years
What is being tested?
CIK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteSouth Korea
Study dates
28 Mar 2022to 17 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • The Catholic University of Korea Seoul St.Mary's Hospital

    Seoul, 06591

Other trials in South Korea

About this study

Official title: An Investigator's Initiated Clinical Study to Evaluate the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.

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?
Read more

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.
Being tested
CIK cells
Keywords
Cytokine-Induced Killer Cells, Hematopoietic Stem Cell Transplantation, Lymphoma, Minimal Residual Disease, CMV, EBV, BKV, Viral infections
Medical subject headings
Lymphoma, Neoplasm, Residual, Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CIK cellsBiological

    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.

Study groups in NCT07692607
Study groupRoleWhat they receive
CIK cellsExperimentalNot described
Receives: Biological: CIK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the baseline visit through 24 months after treatment initiation.

  2. 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.

    Measured: From the screening visit through 24 months after treatment initiation.

Secondary outcomes (3)
  1. 2-Year Overall Survival (OS) Ratio

    • Overall survival (OS) time is defined as the period from the date of autologous hematopoietic transplantation to the date of event.
    • An event is defined as 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.

    Measured: From the screening visit through 24 months after treatment initiation.

  2. Immunological Assessment and Immune Reconstitution

    T cell reconstitution before and after the CIK infusion is assessed using flow cytometry and cytokine expression assays.

    Measured: From the screening visit through 24 months after treatment initiation.

  3. Viral Reconstitution

    CMV, EBV, and BKV reactivation, along with infection-related complications, are assessed to evaluate the safety and efficacy of the CIK cells.

    Measured: From the screening visit through 24 months after treatment initiation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2026
  2. Study start28 Mar 2022
  3. Primary completion11 Feb 2025
  4. Study completion17 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07692607
Sponsor's protocol ID
LB-AT-CIK-AS-AD-CR
Status last verified
Jul 2026
First submitted
2 Jul 2026
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21986635
  • 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.

    PubMed 21664472
  • 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.

    PubMed 17606446
  • 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.

    PubMed 26768688
  • 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.

    PubMed 28712935
  • 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.

    PubMed 30878607
  • 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.

    PubMed 19294626
  • 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.

    PubMed 15744236
  • 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.

    PubMed 10576658
  • 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.

    PubMed 25890480
  • 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.

    PubMed 32484595
  • 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.

    PubMed 28679475
  • 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.

    PubMed 22500889
  • 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.

    PubMed 25196601
  • 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.

    PubMed 41520915

Questions about this trial

What is this clinical trial studying?

A study testing CIK cells in people with Autologous Hematopoietic Stem Cell Transplant, run by LucasBio at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event Assessment (time frame: From the baseline visit through 24 months after treatment initiation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07692607, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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