Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors

NCT ID: NCT05949775

Last Updated: 2023-07-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-20
• Study Completion Date: 2026-03-20

Brief Summary

This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.

Conditions

Advanced Malignant Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

single arm

Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days

Group Type: EXPERIMENTAL

Neoantigen mRNA Personalised Cancer vaccine

Intervention Type: BIOLOGICAL

Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection

Interventions

Neoantigen mRNA Personalised Cancer vaccine

Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Are ≥18 years old, without limitation of sex at time of consent.
• Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
• Fresh biopsy specimens can be provided for vaccine preparation.
• Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H

Exclusion Criteria

• It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
• The predicted number of new antigens is less than 10;
• Those who are pregnant or breastfeeding;
• Those with an expected survival period of less than 3 months;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Cancer Hospital & Institute

OTHER

Sponsor Role: collaborator

Stemirna Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2020-06-mRNA-COM

Identifier Type: -

Identifier Source: org_study_id