Autologous Hematopoietic Stem Cell Transplant
Conditions
Keywords
Cytokine-Induced Killer Cells, Hematopoietic Stem Cell Transplantation, Lymphoma, Minimal Residual Disease, CMV, EBV, BKV, Viral infections
Brief 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.
Interventions
BIOLOGICALCIK 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
LucasBio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event Assessment | 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. |
| 2-Year Progression-Free Survival (PFS) Ratio | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 2-Year Overall Survival (OS) Ratio | 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. |
| Immunological Assessment and Immune Reconstitution | 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. |
| Viral Reconstitution | 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. |
Countries
South Korea
Contacts
PRINCIPAL_INVESTIGATORSeok-Goo Cho, MD-PhD
Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital
Outcome results
None listed