Natural Killer (NK) Cell Therapy in Locally Advanced HCC

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.

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.