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

July 2, 2026 updated by: SeokGoo Cho, LucasBio

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?

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 06591
        • The Catholic University of Korea Seoul St.Mary's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CIK cells
Biological: CIK cells
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event Assessment
Time Frame: From the baseline visit through 24 months after treatment initiation.
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
Time Frame: From the screening visit through 24 months after treatment initiation.
  • 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-Year Overall Survival (OS) Ratio
Time Frame: From the screening visit through 24 months after treatment initiation.
  • 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.
From the screening visit through 24 months after treatment initiation.
Immunological Assessment and Immune Reconstitution
Time Frame: From the screening visit through 24 months after treatment initiation.
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
Time Frame: From the screening visit through 24 months after treatment initiation.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LucasBio

Investigators

  • Principal Investigator: Seok-Goo Cho, MD-PhD, Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2022

Primary Completion (Actual)

February 11, 2025

Study Completion (Actual)

March 17, 2026

Study Registration Dates

First Submitted

July 2, 2026

First Submitted That Met QC Criteria

July 2, 2026

First Posted (Actual)

July 9, 2026

Study Record Updates

Last Update Posted (Actual)

July 9, 2026

Last Update Submitted That Met QC Criteria

July 2, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LB-AT-CIK-AS-AD-CR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Autologous Hematopoietic Stem Cell Transplant

Clinical Trials on CIK cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe