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Evaluation of the Safety of Cytokine-Induced-Killer Cells During Early Transplant Period of Autologous Hematopoietic Stem Cell Transplant Recipients.

2. juli 2026 opdateret af: SeokGoo Cho, LucasBio

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

25

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Sydkorea
      • Seoul, Sydkorea, 06591
        • The Catholic University of Korea Seoul St.Mary's Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: CIK celler
Biologisk: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse Event Assessment
Tidsramme: 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.
From the baseline visit through 24 months after treatment initiation.
2-Year Progression-Free Survival (PFS) Ratio
Tidsramme: 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.
From the screening visit through 24 months after treatment initiation.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
2-Year Overall Survival (OS) Ratio
Tidsramme: 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.
From the screening visit through 24 months after treatment initiation.
Immunological Assessment and Immune Reconstitution
Tidsramme: 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.
From the screening visit through 24 months after treatment initiation.
Viral Reconstitution
Tidsramme: 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.
From the screening visit through 24 months after treatment initiation.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

LucasBio

Efterforskere

  • Ledende efterforsker: Seok-Goo Cho, MD-PhD, Department of Hematology, The Catholic University of Korea Seoul St.Mary's Hospital

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. marts 2022

Primær færdiggørelse (Faktiske)

11. februar 2025

Studieafslutning (Faktiske)

17. marts 2026

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

9. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

9. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • LB-AT-CIK-AS-AD-CR

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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