Natural Killer (NK) Cell Therapy in Locally Advanced HCC

Vaxcell Bio, Co., Ltd.17 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Hepatocellular Carcinoma

Interventions

Vax-NK/HCCBIOLOGICAL

autologous NK cells expanded ex vivo.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

Seon-Ah Ha

Hwasun, Jeollanam-do, South Korea

Outcomes

Primary Outcomes

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.

Time frame: average 6 months

Secondary Outcomes

Disease control rate (DCR) 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), partial response (PR), and stable disease (SD) of administering VAX-NK/HCC combined with HAIC.

Time frame: average 6 months

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

TTP will be measured by time to progression, defined as time from enrollment to disease progression.

Time frame: average 6 months

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

OS will be measured as time from enrollment to death due to any cause.

Time frame: average 12 months

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

The assessment will be performed using the Korean versions of European Organization for Research and Treatment of Cancer (EORTC) Questionnaire 30 (QLQ-C30) consisting of 30 items. Total score: Range 0-100.

Time frame: average 6 months

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

The assessment will be measured by determining the number of patients that experience AEs and SAEs graded according to the NCI-CTCAE (Version 4.0)

Data from ClinicalTrials.gov

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