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

Not Applicable

Not yet recruiting

• Conditions: Advanced Malignant Solid Tumors
• Interventions: Biological: Neoantigen mRNA Personalised Cancer vaccine

• Registration Number: NCT05949775
• Lead Sponsor: Stemirna Therapeutics

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study First Submitted: 2023-06-28
• Study First Submitted QC: 2023-07-16
• Last Update Submitted: 2023-07-16
• Study First Posted: 2023-07-18
• Last Update Posted: 2023-07-18
• Study Start: 2023-07-20
• Primary Completion: 2025-12-12
• Study Completion: 2026-03-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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;

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Neoantigen mRNA Personalised Cancer vaccine	Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days

Primary Outcome Measures

Name	Time	Method
progression-free survival (PFS)	Time Frame: from enrolling to patients disease progression，assessed up to 24 months