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

Launched by STEMIRNA THERAPEUTICS · Jul 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for patients with advanced malignant solid tumors, which are types of cancers that form in solid organs, like the stomach or lungs. The treatment being tested combines a personalized mRNA vaccine that helps the body recognize and attack cancer cells with a medication called Sintilimab. The goal is to see if this combination is safe and effective for patients who have already tried other therapies but their cancer has returned or stopped responding to treatment.

To participate in the trial, individuals need to be at least 18 years old and have a confirmed diagnosis of a malignant solid tumor with at least one measurable tumor. They should also have a fresh biopsy available for the development of the vaccine. However, certain individuals may not qualify, such as those with known allergies to the vaccine or Sintilimab, or those who are pregnant or breastfeeding. Participants can expect to receive careful monitoring throughout the study as researchers evaluate how well the treatment works and its safety. It's important to know that this trial is not yet recruiting participants, so there will be a waiting period before it starts.

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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;