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

NCT03393416 | Unknown Phase 1

• 1 other identifier: MASCT-I-1003
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

MASCT-I

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events（Safety）

  All the local reactions, systemic reactions, adverse events and serious adverse events of all the patients obtained in 14 days after the first treatment cycle of the first course of treatment in this study

  The first 7 weeks

Study Arms (1)

MASCT-I or MASCT-I +PD1 antibody

EXPERIMENTAL

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. 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. The third stage is the dose expansion stage , 10 patients in the low or high dose group were treated with the corresponding dose group.

Biological: MASCT-I; Drug: PD1 antibody

Interventions

MASCT-I BIOLOGICAL

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.

MASCT-I or MASCT-I +PD1 antibody

PD1 antibody DRUG

Drug: PD1 antibody 1mg/kg or 3mg/kg. Administration is conducted in Day1 and Day15. Conducted until disease progression, intolerance or end of study.

Also known as: SHR-1210

MASCT-I or MASCT-I +PD1 antibody

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The age is 18-70 years old.
• The written informed consent of the patient / legal representative is obtained before any program related implementation.
• Metastatic or non resectable, locally advanced gastric or gastroesophageal adenocarcinoma, confirmed by histology or cytology.
• The development of objective imaging after first-line chemotherapy (RECIST1.1);
• There were measurable lesions (according to RECIST1.1);
• Can provide tumor tissue specimens;
• PDL1 positive (only for the second, third stage) or MSI test positive;
• Time interval to last chemotherapy is at least 1 month.
• ECOG score
• The expected survival time is more than 4 months
• Peripheral blood cell culture showes the proliferation of lymphocytes

You may not qualify if:

• Participate in the plan or implementation of the research (including staff of HRYZ and the staff of the research center);
• Participate into other clinical studies at the same time, unless it is an observational (non - intervention) clinical study;
• Subjects may receive other systemic antitumor treatment during the study.
• Squamous or undifferentiated gastric cancer
• There were active bleeding, ulcers, gastrointestinal perforation, fistula, or arterial embolism in the gastrointestinal tract within 6 months.
• There were clinically significant gastrointestinal bleeding or venous thrombosis in three months before enrollment.
• End-stage cachexia patients;
• Patients with severe coagulation dysfunction;
• Patients with extensive abdominal adhesions;
• Patients with intestinal obstruction;
• Pregnancy or planned pregnancy;
• Refusing to provide blood specimens;
• Hypersensitivity to sodium citrate;
• Subjects have received allogeneic transplantation
• Subjects had clinical symptoms of central nervous system metastasis (such as brain edema, requiring hormone intervention, or progression of brain metastases)

Sponsors & Collaborators

• HRYZ Biotech Co.: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Interventions

spartalizumab; camrelizumab

Study Officials

• Jiafu JI, Doctor

  Cancer Hospital Affiliated to Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brent XU, Bachelor

CONTACT

+86 13922171358; xuyizhou@shhryz.com

Aimin ZHU, Bachelor

CONTACT

+86 13901216489; zhuaiming@shhryz.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 27, 2017
• First Posted: January 8, 2018
• Study Start: April 19, 2018
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 29, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)