NCT01995227

An Individualized Anti-Cancer Vaccine Study in Patients With HCC

An Individualized Anti-Cancer Vaccine (AlloVaxTM) Study in Patients With Refractory Hepatocellular Carcinoma (HCC)

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the safety and the immunological, radiological, and pathological response of the personalized anti-cancer vaccine AlloVax(TM) in patients with refractory Hepatocellular Carcinoma (HCC) and who are not eligible for any approved HCC treatments or have failed all approved HCC treatments. AlloVax(TM) is a personalized anti-cancer vaccine combining Chaperone Rich Cell Lysate (CRCL) as a source of tumor antigen prepared from patient's tumor and AlloStim(TM) as an adjuvant. The combination of these two components provides a vaccine designed to bring out an immune response capable of finding and killing the tumor cells.

Detailed description

All accrued subjects will undergo tumor harvest procedure. The tumor samples will be processed into personalized Chaperone Rich Cell Lysate (CRCL) vaccine. This study consists of three phases: priming phase, vaccination phase, and activation phase. The priming phase involves intradermal injections of AlloStim(TM). The aim of this phase is to increase the titer of Th1 immune cells in circulation. The vaccination phase involves the intradermal injections of AlloSim(TM) immediately followed by the intradermal injections of CRCL. This phase is designed to elicit tumor-specific immunity. The activation phase involves intravenous infusion of AlloStim(TM). This phase is designed to activate memory cells and NK cells and cause them to extravasate and traffic to tumor sites.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	AlloVax	Personalized anti-cancer vaccine
BIOLOGICAL	CRCL	Personalized anti-cancer vaccine
BIOLOGICAL	AlloStim	ID injections IV infusion

Timeline

• Start date: 2013-12-01
• Primary completion: 2018-02-01
• Completion: 2018-07-01
• First posted: 2013-11-26
• Last updated: 2020-01-22

Locations

1 site across 1 country: Israel