NCT03393416

A Phase I Clinical Study for Evaluating the Safety of MASCT-I in Advanced Soild Tumor

A Single Center, Phase I Clinical Study to Evaluate the Safety of MASCT-I Combined With PD1 Antibody in Vivo for the Advanced Soild Tumor Including Gastric Cancer，Triple-negative Breast Cancer and Ovarian Cancer

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: HRYZ Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study evaluate the safety and tolerance of MASCT-I(multiple-antigen specific cell therapy) combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy. The study is divided into three stages: the first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The patients would be treated with MASCT-I single drug therapy, MASCT-I+ low dose PD1 antibody therapy, and MASCT-I+ high dose PD1 antibody therapy.

Detailed description

The multiple-antigen specific cell therapy which was developed by Hengrui Yuanzheng is optimized continuously and has been upgraded from the first-generation MASCT technology to MASCT-I. MASCT-I is to add PD1 antibody in vitro cell culture process of MASCT technology to block PD1 receptor on immunocytes, relieving the brake at immunocytes' reinfusion and interaction with tumor cells for enhancing the effectiveness of immunocytes killing tumor cells. This is a phase I study to evaluate the safety and tolerance of MASCT-I combined with PD1 antibody in patients with advanced gastric cancer who failed in first-line chemotherapy. About 19-28 cases patients with advanced gastric cancer are to be recruited. This study is divided into three stages: The first, second stage is the stage of the dose climbing, and the third stage is the dose expansion stage. The first stage is MASCT-I, using 3+3 design, if the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells,the experiment will be end. If the DLT\<33.3%, enter the second stage. The second stage is divided into two groups: MASCT-I+PD1 antibody in low dose group and MASCT-I+PD1 antibody in high dose group, using 3+3 design, if all patients in low dose group, the DLT≥33.3% from the mononuclear cell collection to 14 days after the first MASCT-I infusion of T cells, the experiment will be end. If DLT\<33.3% began high dose group. If all the patients in the high dose group, DLT ≥33.3%, the corresponding high dose group treatment will be terminated, entered the third stage, the dose of expansion, only by low dose treatment group of 10 patients of reentry. If all the patients in the high dose group, DLT\<33.3%, entered the third stage. Only 10 patients in the high dose group were treated with the corresponding high-dose group.

Conditions

• Advanced Gastric Cancer

Interventions

Type	Name	Description
BIOLOGICAL	MASCT-I	The final products of MASCT-I(Multiple-antigen specific cell therapy) technology are dendritic cells (DC) and effector T cells.Treatment with MASCT-I alone, conducted until disease progression, intolerance or end of study.
DRUG	PD1 antibody	Drug: PD1 antibody 1mg/kg or 3mg/kg. Administration is conducted in Day1 and Day15. Conducted until disease progression, intolerance or end of study.

Timeline

• Start date: 2018-04-19
• Primary completion: 2020-07-01
• Completion: 2020-07-01
• First posted: 2018-01-08
• Last updated: 2019-08-29

Locations

1 site across 1 country: China