Status:
UNKNOWN
A Phase I Clinical Study for Evaluating the Safety of MASCT-I in Advanced Soild Tumor
Lead Sponsor:
HRYZ Biotech Co.
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Conditions:
Advanced Gastric Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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 chemotherap...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03393416
Start Date
April 19 2018
End Date
July 1 2020
Last Update
August 29 2019
Active Locations (1)
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1
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142