NCT03034304

A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors

Multi-center, Phase I Clinical Study to Evaluate the Safety and Tolerability of Multiple Antigen Stimulating Cellular Therapy-I (MASCT-I) in Patients With Advanced Solid Tumor, and to Preliminarily Evaluate the Anti-tumor Efficacy of MASCT-I Alone, in Combination With Chemical Drugs, and in Combination With PD1 Antibody

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: HRYZ Biotech Co. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate Safety and tolerability of MASCT-I in patients with advanced solid tumors, either alone or in combination with chemical drugs or in combination with PD1 antibody.

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 a technology which add PD1 antibody in vitro cell culture process of MASCT cell culture to block PD1 receptor on immunocytes, release the brake on immunocytes' reinfusion and interaction with tumor cells for enhancing the efficacy of immunocytes' killing tumor cells. At present, the development and validation of manufacturing process has been completed, and it is urgently needed to conduct the validation of clinical effect. This is a Multi-center, phase I clinical study to evaluate the safety and tolerability of multiple antigen stimulating cellular therapy-I (MASCT-I) in patients with advanced solid tumor, and to preliminarily evaluate the anti-tumor efficacy of MASCT-I alone, in combination with chemical drugs, and in combination with PD1 antibody. About 193 cases of adult patients with advanced solid tumors will be recruited.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MASCT-I	The final products of MASCT-I technology are dendritic cells (DC) and effector T cells
DRUG	Ifosfamide	2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles
DRUG	PD1 antibody	200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.
DRUG	Adriamycin	60mg/m2, from the first day of each cycle, it is used for 1-2 days, intravenous drip. Repeat the above cycle after 4 weeks, no more than 8 cycles
DRUG	Gemcitabine	1000 mg/m2, Intravenous drip for about 30 min, used on the first and eighth days of each cycle, and every 3-4 weeks as a cycle
DRUG	Cisplatin	70mg/m2, Use on the first day of each chemotherapy cycle, intravenous drip for 30-120 min, and every 3-4 weeks as a cycle;
DRUG	Carboplatin	5mg/ml/min, Use it on the first day of each chemotherapy cycle, intravenous drip for 30 minutes, and every 3-4 weeks as a cycle

Timeline

• Start date: 2017-02-22
• Primary completion: 2023-11-13
• Completion: 2023-11-13
• First posted: 2017-01-27
• Last updated: 2025-07-24

Locations

9 sites across 1 country: China