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Trial Title:
Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors
NCT ID:
NCT05949775
Condition:
Advanced Malignant Solid Tumors
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
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.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Neoantigen mRNA Personalised Cancer vaccine
Description:
Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab
Injection Subcutaneous Injection
Arm group label:
single arm
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.
Criteria for eligibility:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
July 20, 2023
Completion date:
March 20, 2026
Lead sponsor:
Agency:
Stemirna Therapeutics
Agency class:
Industry
Collaborator:
Agency:
Peking University Cancer Hospital & Institute
Agency class:
Other
Source:
Stemirna Therapeutics
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05949775
