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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05949775
Recruitment Status : Not yet recruiting
First Posted : July 18, 2023
Last Update Posted : July 18, 2023
Sponsor:
Collaborator:
Peking University Cancer Hospital & Institute
Information provided by (Responsible Party):
Stemirna Therapeutics

Study Description
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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
Advanced Malignant Solid Tumors Biological: Neoantigen mRNA Personalised Cancer vaccine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
Estimated Study Start Date : July 20, 2023
Estimated Primary Completion Date : December 12, 2025
Estimated Study Completion Date : March 20, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Stemirna Therapeutics
ClinicalTrials.gov Identifier: NCT05949775    
Other Study ID Numbers: 2020-06-mRNA-COM
First Posted: July 18, 2023    Key Record Dates
Last Update Posted: July 18, 2023
Last Verified: June 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms