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

Advanced Malignant Solid Tumors Clinical Trial

Official title:

Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949775
• Other study ID #: 2020-06-mRNA-COM
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 20, 2023
• Est. completion date: March 20, 2026

Study information

• Verified date: June 2023
• Source: Stemirna Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: March 20, 2026
• Est. primary completion date: December 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumors
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stemirna Therapeutics	Peking University Cancer Hospital & Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival (PFS)		Time Frame: from enrolling to patients disease progression,assessed up to 24 months