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Clinical Study of mRNA Vaccine in Patients With Advanced Malignant Solid Tumors | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGNA

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

Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA

NCT05949775•Stemirna Therapeutics

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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;

Key Dates

Start Date

July 20, 2023

Primary Completion Date

December 12, 2025

Completion Date

March 20, 2026

Last Updated

July 18, 2023

Enrollment

ESTIMATED participants

Conditions

Advanced Malignant Solid Tumors

Interventions

Neoantigen mRNA Personalised Cancer vaccine

BIOLOGICAL

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

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RECRUITINGPHASE1

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B7-H3-positive Advanced Malignant Solid Tumors Advanced Primary Peritoneal Tumors or Secondary Abdominal Metastatic Malignant Solid Tumors

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A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

MT027 in Patients With Advanced Peritoneal Malignancies or Abdominal Metastatic Solid Tumors

A Phase II Clinical Study Evaluating the Safety, Tolerability,Pharmacokinetics, and Preliminary Efficacy of JS212 andJS213 as Monotherapy and in Combination in Patients Withadvanced Malignant Solid Tumors

Clinical Study of MNC-168 Enteric-coated Capsule in the Treatment of Advanced Intestinal Solid Tumor

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