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

NCT03393416 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-08-29

No results posted yet for this study

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.

Conditions

  • Advanced Gastric Cancer

Interventions

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.

Sponsors & Collaborators

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • HRYZ Biotech Co.

    lead INDUSTRY

Principal Investigators

  • Jiafu JI, Doctor · Cancer Hospital Affiliated to Peking University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-19
Primary Completion
2020-07-31
Completion
2020-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03393416 on ClinicalTrials.gov