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

NCT05949775 | Not Yet Recruiting

• 1 other identifier: 2020-06-mRNA-COM
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• progression-free survival (PFS)

  Time Frame: from enrolling to patients disease progression，assessed up to 24 months

Study Arms (1)

single arm

EXPERIMENTAL

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

Biological: Neoantigen mRNA Personalised Cancer vaccine

Interventions

Neoantigen mRNA Personalised Cancer vaccine BIOLOGICAL

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

single arm

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Stemirna Therapeutics: lead
• Peking University Cancer Hospital & Institute: collaborator

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PD-1/PD-L1 drug therapy benefits patients with secondary drug-resistant malignant solid tumors, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H.

Study Record Dates

• First Submitted: June 28, 2023
• First Posted: July 18, 2023
• Study Start: July 20, 2023
• Primary Completion: December 12, 2025
• Study Completion: March 20, 2026
• Last Updated: July 18, 2023

Record last verified: 2023-06