NCT05040438

Natural Killer (NK) Cell Therapy in Locally Advanced HCC

Completed Phase 2 Last updated 30 April 2024

What this trial tests

Phase 2 trial testing Vax-NK/HCC in Locally Advanced Hepatocellular Carcinoma in 17 participants. Completed in 14 September 2023.

Timeline

15 October 2019

Primary endpoint
14 September 2023

14 September 2023

Quick facts

Lead sponsor	Vaxcell Bio, Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	17
Start date	15 October 2019
Primary completion	14 September 2023
Estimated completion	14 September 2023
Sites	1 location across South Korea

Drugs / interventions tested

• Vax-NK/HCC — full drug profile →

Conditions studied

• Locally Advanced Hepatocellular Carcinoma — all drugs for Locally Advanced Hepatocellular Carcinoma →

Sponsor

Vaxcell Bio, Co., Ltd. — full company profile →

Who can join

19 and older, any sex, with Locally Advanced Hepatocellular Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NK cells and solid tumors: therapeutic potential and persisting obstacles.
   Tong L, Jiménez-Cortegana C, Tay AHM, Wickström S, et al · · 2022 · cited 134× · PMID 36319998 · DOI 10.1186/s12943-022-01672-z
2. Challenges and Recent Advances in NK Cell-Targeted Immunotherapies in Solid Tumors.
   Lian G, Mak TS, Yu X, Lan HY. · · 2021 · cited 44× · PMID 35008589 · DOI 10.3390/ijms23010164
3. Recent Progress in Systemic Therapy for Advanced Hepatocellular Carcinoma.
   Sadagopan N, He AR. · · 2024 · cited 26× · PMID 38279258 · DOI 10.3390/ijms25021259
4. The Important Roles of Natural Killer Cells in Liver Fibrosis.
   Yang M, Vanderwert E, Kimchi ET, Staveley-O'Carroll KF, et al · · 2023 · cited 11× · PMID 37239062 · DOI 10.3390/biomedicines11051391
5. Natural killer cell therapy in hepatocellular carcinoma: a comprehensive review.
   Tavakoli S, Samareh-Salavati M, Rahnama MA, Abdolahi S, et al · · 2025 · cited 2× · PMID 40668523 · DOI 10.1007/s12672-025-03138-2
6. Extracellular Metabolites and Natural Killer Cell Antitumor Function: Mechanisms and Therapeutic Strategies
   Zang R, Zhang C, Fu Y, Chen J, et al ·
7. Mechanisms of innate immune cells in Metabolic dysfunction-associated steatotic liver disease.
   Yao Y, Wu Q, Fan B, Peng X, et al · · 2025 · PMID 41080565 · DOI 10.3389/fimmu.2025.1599748
8. KIR2DS2+ NK cells in cancer patients demonstrate high activation in response to tumour-targeting antibodies.
   Graham LV, Fisher JG, Doyle ADP, Sale B, et al · · 2024 · PMID 39286025 · DOI 10.3389/fonc.2024.1404051