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

August 27, 2019 updated by: SYZ Cell Therapy Co..

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

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.

Study Overview

Status

Unknown

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.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100142
        • Recruiting
        • Beijing Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • 0-1 ECOG score
  • The expected survival time is more than 4 months
  • Peripheral blood cell culture showes the proliferation of lymphocytes

Exclusion Criteria:

  • 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)
  • Subjects are using immunosuppressive agents, or whole body or absorbable local hormone therapy to achieve the aim of immunosuppression (dose >10mg/ days prednisone or other therapeutic hormones) and continue to use in the first 2 weeks before enrollment.
  • Systemic or long-term application of immunomodulators, such as interferon, thymosin, and immunosuppressive drugs, in half a year.
  • Subjects had been treated with MASCT or other cellular immunotherapy within a year.
  • Subjects had any active autoimmune disease or a history of autoimmune disease.
  • Active tuberculosis
  • There is a big operation in 30 days before the first study treatment.
  • Patients with active hepatitis B virus (HBV) infection (chronic or acute)
  • The infection of active hepatitis C virus (HCV)
  • Suffering from human immunodeficiency virus (HIV) or syphilis
  • A history of peripheral nervous system disorder or a history of obvious mental disorders and central nervous system disorders
  • Subjects had active infection or >38.5 degree of unexplained fever in the screening period and before the first administration.
  • Chronic systemic diseases, such as liver disease (such as cirrhosis, etc.), kidney disease, respiratory disease, or non controlled diabetes, hypertension, etc.
  • There were other malignant tumors in 5 years, except for non melanin skin cancer and cervical carcinoma in situ
  • There are heart symptoms or diseases that have not been well controlled.
  • Subjects were known to have a history of psychotropic drug abuse, alcoholism, or drug abuse.
  • According to the researchers, there are other factors that may lead to a halt.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MASCT-I or MASCT-I +PD1 antibody

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.

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

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

Other Names:
  • SHR-1210

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events(Safety)
Time Frame: The first 7 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jiafu JI, Doctor, Cancer Hospital Affiliated to Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

December 27, 2017

First Submitted That Met QC Criteria

January 2, 2018

First Posted (Actual)

January 8, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2019

Last Update Submitted That Met QC Criteria

August 27, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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