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

Sponsor
Stemirna Therapeutics (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05949775
Collaborator
Peking University Cancer Hospital & Institute (Other)
20
Enrollment
1
Arm
32
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Neoantigen mRNA Personalised Cancer vaccine
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
Anticipated Study Start Date :
Jul 20, 2023
Anticipated Primary Completion Date :
Dec 12, 2025
Anticipated Study Completion Date :
Mar 20, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: single arm

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

Outcome Measures

Primary Outcome Measures

  1. progression-free survival (PFS) [Time Frame: from enrolling to patients disease progression，assessed up to 24 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Stemirna Therapeutics
  • Peking University Cancer Hospital & Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stemirna Therapeutics
ClinicalTrials.gov Identifier:
NCT05949775
Other Study ID Numbers:
  • 2020-06-mRNA-COM
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Jul 18, 2023