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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
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.
The Catholic University of Korea Seoul St.Mary's Hospital
Seoul, South Korea
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.
Time frame: 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.
Time frame: From the screening visit through 24 months after treatment initiation.
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.
Time frame: From the screening visit through 24 months after treatment initiation.
Immunological Assessment and Immune Reconstitution
T cell reconstitution before and after the CIK infusion is assessed using flow cytometry and cytokine expression assays.
Time frame: From the screening visit through 24 months after treatment initiation.
Viral Reconstitution
CMV, EBV, and BKV reactivation, along with infection-related complications, are assessed to evaluate the safety and efficacy of the CIK cells.
Time frame: From the screening visit through 24 months after treatment initiation.
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