Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2026-01-02 @ 5:36 AM
Study NCT ID:
NCT03034304
Status:
TERMINATED
Last Update Posted:
2025-07-24
First Post:
2016-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Clinical Study for Evaluating the Safety and Efficacy of MASCT-I in Patients With Advanced Solid Tumors
Sponsor:
HRYZ Biotech Co.
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study was terminated early due to the COVID-19 pandemic and sponsor's funding constraints, based on promising preliminary safety and efficacy data.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: