Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
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ClinicalTrials.gov Identifier: NCT05949775 |
Recruitment Status :
Not yet recruiting
First Posted : July 18, 2023
Last Update Posted : July 18, 2023
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Sponsor:
Stemirna Therapeutics
Collaborator:
Peking University Cancer Hospital & Institute
Information provided by (Responsible Party):
Stemirna Therapeutics
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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 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 |
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
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Biological: Neoantigen mRNA Personalised Cancer vaccine
Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection |
Primary Outcome Measures :
- progression-free survival (PFS) [ Time Frame: Time Frame: from enrolling to patients disease progression,assessed up to 24 months ]
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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;
No Contacts or Locations Provided
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Neoplasms |