Natural Killer (NK) Cell Therapy in Locally Advanced HCC

NCT05040438 | Completed Phase 2 DMC

• 1 other identifier: Vax-NK/HCC-201
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) of administering VAX-NK/HCC combined with HAIC

  ORR will be measured as the proportion of patients with a best overall response of complete response (CR) and partial response (PR) of administering VAX-NK/HCC combined with HAIC.

  average 6 months

Secondary Outcomes (9)

• Disease control rate (DCR) of administering VAX-NK/HCC combined with HAIC

  average 6 months

• Time to progression (TTP) of administering VAX-NK/HCC combined with HAIC

  average 6 months

• Overall survival (OS) of administering VAX-NK/HCC combined with HAIC

  average 12 months

• Quality of Life of administering VAX-NK/HCC combined with HAIC

  average 6 months

• Adverse Events (AEs) and Serious Adverse Events (SAEs) of administering VAX-NK/HCC combined with HAIC

  average 6 months

Study Arms (1)

Autologous NK cell infusion combined with HAIC

EXPERIMENTAL

HAIC of 5-FU (500 mg/m2, Q4W) and cisplatin (15 mg/m2, Q4W) will be administered for up to 4 cycles to patients with locally advanced HCC. Subjects who achieved sustained SD or better based on the mRECIST criteria after 2nd cycle of HAIC will be enrolled to receive 1x10\^9 cells VAX-NK/HCC infusion.

Biological: Vax-NK/HCC

Interventions

Vax-NK/HCC BIOLOGICAL

autologous NK cells expanded ex vivo.

Autologous NK cell infusion combined with HAIC

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with intermediate and/or locally advanced HCC histologically confirmed by biopsy or by typical radiological findings.
• Subjects who were not suitable for or failed curative treatments such as surgical resection, local ablation therapy, transarterial chemoembolization (TACE), sorafenib, atezolizumab, bevacizumab, etc.
• Child-Pugh liver function class A or B.
• Subjects' ECOG performance status of 0 or 1.
• The presence of macrovascular invasion.
• Adequate liver, renal, and hematologic functions.

You may not qualify if:

• Subjects who received the immune cell-based therapy within 6 months before the screening visit.
• Subjects with a history of a malignancy other than HCC within the last 5 years, liver transplantation, and hypersensitivity to 5-FU or cisplatin.
• Subjects with extra-hepatic metastases.
• Subjects who have ongoing autoimmune disease.
• Female subjects who are pregnant or lactating or women of child-bearing potential but unable to take adequate contraception.

Sponsors & Collaborators

• Vaxcell Bio, Co., Ltd.: lead

Study Sites (1)

Seon-Ah Ha

Hwasun, Jeollanam-do, 58141, South Korea

Location

Study Officials

• Seon-Ah Ha, Ph.D.

  VaxCell Biotherapeutics Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 10, 2021
• Study Start: October 15, 2019
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: April 30, 2024

Record last verified: 2023-05

Locations

KR (1)