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Natural Killer (NK) Cell Therapy in Locally Advanced HCC

NCT05040438 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2024-04-30

No results posted yet for this study

Summary

This Phase 2a trial will evaluate the safety and efficacy of NK cell therapy combined with the hepatic artery infusion chemotherapy (HAIC) in patients with intermediate and/or locally advanced hepatocellular carcinoma (HCC). We hypothesized that 5-fluorouracil (FU) with immunomodulatory functions would relieve the immunosuppressive microenvironment from the myeloid-derived suppressor cells (MDSCs), thereby enhancing the anti-tumor activity of NK cells. Thus, the subsequent infusion of autologous NK cells (VAX-NK/HCC) following HAIC treatment may further improve the anti-tumor activity in patients with advanced HCC.

Conditions

  • Locally Advanced Hepatocellular Carcinoma

Interventions

BIOLOGICAL

Vax-NK/HCC

autologous NK cells expanded ex vivo.

Sponsors & Collaborators

  • Vaxcell Bio, Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Seon-Ah Ha, Ph.D. · VaxCell Biotherapeutics Co., Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2023-09-14
Completion
2023-09-14

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05040438 on ClinicalTrials.gov