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

• Status: Unknown status
• Trial end date: 2020-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: SYZ Cell Therapy Co..
• Collaborator: Beijing Cancer Hospital
• Treatments: Antibodies

Criteria

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.