A study to evaluate the safety of immune cell therapy in early transplant period of hematopoietic stem cell transplant recipients

An investigator's initiated trial to evaluate the safety of cytokine-induced killers during early transplant period of autologous hematopoeitic stem cell transplant recipients

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004024

Enrollment

Registered

2019-05-31

Start date

2021-03-08

Completion date

Unknown

Last updated

2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Non-Stem Cell : Product: Autologous cytokine induced killer cells Dose: 1x10e9 to 1x10e10 cells Number of doses: once Injection Time: 14 days after autologous stem cell transpla

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients between ages 17 and 70 years old 2) Lymphoma patients who are expecting an autologous hematopoeitic stem cell transplantation 3) ECOG performance status 0 or 1 4) Those who are considered to survive longer than 3 months 5) Those without acute infectious disease 6) Those who do not have comorbid tumor 7) Patients who voluntarily signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Pregnant women, lactating women, or women who have the possibility of pregnancy or those who have not taken adequate contraceptive measures 2) Sexually active men who do not take proper contraceptive measures 3) Patients with active infection or fever (=38 ?) with unknown etiology or ongoing bacterial or fungal infections 4) Patients under 19 or over 70 years old 5) ECOG performance status 2, 3, 4 6) Patients with previously proven HIV infection, uncontrolled hypertension (diastolic blood pressure> 115 mmHg), unstable angina, congestive heart failure (NY class II or higher), poorly controlled severe diabetes, coronary angioplasty within 6 months, Patients with acute myocardial infarction or non-malignant disease including uncontrolled atrial or ventricular arrhythmia within the past 6 months 7) Patients with mental illness, drug addiction, etc. who are judged to have an influence on the outcome of the study 8) Patients participating in other clinical trials 9) Patients who are judged to be inadequate for a clinical trial by the principal investigator 10) Other serious medical conditions that may reduce compliance with clinical trials

Design outcomes

Primary

Measure	Time frame
2 year- disease free survival of autologous hematopoetic stem cell transplantation;Safety of cytokine-induced killer cell infusion following autologous hematopoeitic stem cell transplantation	—

Secondary

Measure	Time frame
2 year- overall survival of autologous hematopoetic stem cell transplantation;Immunological biomarker analysis after cytokine-induced killer cell infusion;Hematological recovery after cytokine-induced killer cell infusion;Incidence of various latent viruses (CMV, ADV, EBV, BKV, HHV-6) reactivation and infection during early transplant period following cytokine-induced killer cell infusion	—

Countries

Korea, Republic of

Contacts

Public ContactNayoun Kim

The Catholic University of Korea

nancynayounkim@gmail.com+82-2-2258-6907

Outcome results