Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT03908671|
Recruitment Status : Unknown
Verified January 2019 by Stemirna Therapeutics.
Recruitment status was: Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Esophageal Cancer Non Small Cell Lung Cancer||Biological: Personalized mRNA Tumor Vaccine||Not Applicable|
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.
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).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Estimated Study Start Date :||May 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2022|
Experimental: Personalized mRNA Tumor Vaccine
Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with advanced esophageal and non-small cell lung cancers
Biological: Personalized mRNA Tumor Vaccine
subcutaneous injection with personalized mRNA tumor vaccine
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 24 weeks ]
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 (DCR) [ Time Frame: 1.5 years ]Disease Control Rate of Personalized mRNA Tumor Vaccine
- Progression-free Survival (PFS) [ Time Frame: 2 years ]Progression-free Survival of Personalized mRNA Tumor Vaccine
- Time to Tumor Progression (TTP) [ Time Frame: 2 years ]Time to Tumor Progression of Personalized mRNA Tumor Vaccine
- Overall Survival (OS) [ Time Frame: 3 years ]Overall Survival of Personalized mRNA Tumor Vaccine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03908671
|Contact: Li Yangfirstname.lastname@example.org|
|Contact: Yi Zhangemail@example.com|