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

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05949775

Enrollment

Registered

2023-07-18

Start date

2023-07-20

Completion date

2026-03-20

Last updated

2023-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Malignant Solid Tumors

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.

Interventions

BIOLOGICALNeoantigen mRNA Personalised Cancer vaccine

Drug: Neoantigen mRNA Personalised Cancer vaccine in combination with Stintilimab Injection Subcutaneous Injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

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.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame
progression-free survival (PFS)	Time Frame: from enrolling to patients disease progression，assessed up to 24 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026