Clinical trial · Interventional
Evaluation of the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Autologous Hematopoietic Stem Cell Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CIK cells
- interventionNames
- Biological: CIK cells
Primary outcomes (2)
- measure
- Adverse Event Assessment
- timeFrame
- From the baseline visit through 24 months after treatment initiation.
- description
- 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.
- measure
- 2-Year Progression-Free Survival (PFS) Ratio
- timeFrame
- From the screening visit through 24 months after treatment initiation.
- description
- * 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: Patients who meet all of the following criteria: 1. Patients aged 19 to 70 years. 2. Patients with lymphoma who are expected to undergo autologous hematopoietic stem cell transplantation. 3. Patients with the ECOG performance status scale of 0 or 1. 4. Patients with a life expectancy longer than 3 months. 5. Patients without evidence of an acute infectious disease. 6. Patients without evidence of a concomitant malignancy. 7. Individuals who have provided written consent to comply with the restrictions, either by themselves or through their legal guardians. Exclusion Criteria: 1. Female patients who are pregnant, breastfeeding, of childbearing potential, or not using appropriate contraceptive methods. 2. Patients with active infection or fever (≥38°C) of unknown etiology, or ongoing bacterial or fungal infection. 3. Patients aged below 19 years or above 70 years. 4. Patients with the ECOG performance status scale of 2, 3, or 4. 5. 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. 6. Patients with mental illness or drug intoxication that may affect the results of this clinical study. 7. Patients who are participating in another clinical study. 8. Patients deemed ineligible for participation in this clinical study by the investigator. 9. Patients with other severe medical conditions that may compromise compliance with the clinical study.
References
Publications (15)
- BACKGROUNDLinn 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. PMID 21986635
- BACKGROUNDLaport 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. PMID 21664472
- BACKGROUNDIntrona 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. PMID 17606446
- BACKGROUNDRettinger 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
- BACKGROUNDIntrona 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.