Evaluation of the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.
NCT07692607 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-07-09
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
Interventions
- 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.
Sponsors & Collaborators
-
LucasBio
lead INDUSTRY
Principal Investigators
-
Seok-Goo Cho, MD-PhD · Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 19 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-03-28
- Primary Completion
- 2025-02-11
- Completion
- 2026-03-17
Countries
- South Korea
Study Locations
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