Natural Killer (NK) Cell Therapy in Locally Advanced HCC

NCT ID: NCT05040438

Last Updated: 2024-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-15
• Study Completion Date: 2023-09-14

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.

Detailed Description

Primary Objective I. To assess the objective response rate (ORR) of administering VAX-NK/HCC, autologous NK cells combined with HAIC in patients with locally advanced HCC.

Secondary Objectives I. To assess the efficacy of administering VAX-NK/HCC combined with HAIC. II. To assess the safety of administering VAX-NK/HCC combined with HAIC. III. To assess the immune responses of administering VAX-NK/HCC combined with HAIC.

OUTLINE: This is a Phase 2a study. Patients receive HAIC treatment every 4 week for up to 4 cycles followed by ex-vivo expanded autologous NK cell infusions. The NK cell treatment repeats every 4 weeks for up to 2 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients will be followed until the disease progression.

Conditions

Locally Advanced Hepatocellular Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous NK cell infusion combined with HAIC

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.

Group Type: EXPERIMENTAL

Vax-NK/HCC

Intervention Type: BIOLOGICAL

autologous NK cells expanded ex vivo.

Interventions

Vax-NK/HCC

autologous NK cells expanded ex vivo.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vaxcell Bio, Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seon-Ah Ha, Ph.D.

Role: STUDY_DIRECTOR

VaxCell Biotherapeutics Co., Ltd.

Locations

Seon-Ah Ha

Hwasun, Jeollanam-do, South Korea

Countries

South Korea

Other Identifiers

Vax-NK/HCC-201

Identifier Type: -

Identifier Source: org_study_id