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.

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.

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.