Neoplasms

All Conditions

Digestive System Diseases

Carcinoma

Carcinoma, Squamous Cell

Adenocarcinoma

Gastrointestinal Neoplasms

Digestive System Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

All Drugs and Chemicals

Vaccines

Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma

subcutaneous injection with personalized mRNA tumor vaccine at least four times

Personalized mRNA Tumor Vaccine

Bin Wang, Dr.

Xianbao Zhan, Dr.

A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma

Dr. Bin Wang developed the investigational vaccine used in this clinical trial and designed the trial protocol.For patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma tumor who have disease progression with first line chemotherapy. Single or multiple doses of personalized mRNA tumor vaccine encoding neoantigen will be given to observe the safety and efficacy the mRNA tumor vaccine.

Primary objectives:

Determine the safety, tolerability and cytokinetics of the personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma.

Secondary objectives:

Make a preliminary evaluation on the efficacy of personalized mRNA tumor vaccine in patients with advanced esophageal squamous carcinoma, gastric adenocarcinoma, pancreatic adenocarcinoma and colorectal adenocarcinoma with the following parameters:

Time of tumor progression (TTP);

Disease Control Rate (DCR);

Objective Remission Rate (ORR);

Overall Survival (OS).

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms

Clinical Study of Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Squamous Carcinoma, Gastric Adenocarcinoma, Pancreatic Adenocarcinoma and Colorectal Adenocarcinoma

During the trial conduction, especially within the 24 weeks of treatment phase when mRNA tumor Vaccine administered, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE (v 3.0) will be recorded, including but not limited to the toxicities potentially suspected to relate to injection procedures and/or mRNA Tumor Vaccine therapy as listed below:

* Fever
* Chills
* Nausea, vomiting and other gastrointestinal symptoms
* Fatigue
* Hypotension
* Respiratory distress
* Tumor lysis syndrome
* Neutropenia, thrombocytopenia
* Liver and kidney dysfunction

Stemirna Therapeutics

Changhai Hospital

Attending physician

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Esophageal Neoplasms

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with advanced esophageal and non-small cell lung cancers

subcutaneous injection with personalized mRNA tumor vaccine

Li Yang

Yi Zhang

Yi Zhang, Doctor

A single arm, open-label pilot study is designed to determine the safety, tolerability and effectiveness of personalized mRNA tumor vaccine encoding neoantigen in Patients with advanced esophageal cancer and non-small cell lung cancer

Primary objectives:

Assessing the safety and tolerability of mRNA personalized tumor vaccines encoding neoantigen for unresectable or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment.

Secondary objectives:

Preliminary observation of the efficacy of mRNA personalized tumor vaccines encoding neoantigen for unsurgically resected or metastatic advanced esophageal and non-small cell lung cancers with standard treatment failure or no standard treatment.

Time of tumor progression (TTP); Disease Control Rate (DCR); Objective Remission Rate (ORR); Overall Survival (OS).

Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer

Clinical Trial on the Safety and Efficacy of Neoantigen Antigen mRNA Tumor Vaccine in the Treatment of Advanced Esophageal Cancer and Non-small Cell Lung Cancer

During the trial conduction, especially within the 24 weeks of treatment phase when mRNA tumor Vaccine administered, all adverse events (including laboratory abnormality and clinical events) will be closely monitored, and all ≥ grade 3 adverse events per CTCAE will be recorded, including but not limited to the toxicities potentially suspected to relate to injection procedures and/or mRNA Tumor Vaccine therapy as listed below:

Fever Chills Nausea, vomiting and other gastrointestinal symptoms Fatigue Hypotension Respiratory distress Tumor lysis syndrome Neutropenia, thrombocytopenia Liver and kidney dysfunction Neutropenia, thrombocytopenia Liver and kidney dysfunction

Disease Control Rate of Personalized mRNA Tumor Vaccine

Progression-free Survival of Personalized mRNA Tumor Vaccine

Time to Tumor Progression of Personalized mRNA Tumor Vaccine

Overall Survival of Personalized mRNA Tumor Vaccine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms	NCT03468244	Advanced Esopha... Gastric Adenoca... Pancreatic Aden... Colorectal Aden...	Personalized mR...	18 Years - 75 Years	Changhai Hospital
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Digestive System Neoplasms	NCT03468244	Advanced Esopha... Gastric Adenoca... Pancreatic Aden... Colorectal Aden...	Personalized mR...	18 Years - 75 Years	Changhai Hospital
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer	NCT03908671	Esophageal Canc... Non Small Cell ...	Personalized mR...	18 Years - 75 Years	Stemirna Therapeutics

Spots Global Cancer Trial Database for personalized mrna tumor vaccine