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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03908671
Recruitment Status : Not yet recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
Sponsor:
Collaborator:
The First Affiliated Hospital of Zhengzhou University
Information provided by (Responsible Party):
Stemirna Therapeutics

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Esophageal Cancer Non Small Cell Lung Cancer Biological: Personalized mRNA Tumor Vaccine Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: 1.5 years ]
    Disease Control Rate of Personalized mRNA Tumor Vaccine

  2. Progression-free Survival (PFS) [ Time Frame: 2 years ]
    Progression-free Survival of Personalized mRNA Tumor Vaccine

  3. Time to Tumor Progression (TTP) [ Time Frame: 2 years ]
    Time to Tumor Progression of Personalized mRNA Tumor Vaccine

  4. Overall Survival (OS) [ Time Frame: 3 years ]
    Overall Survival of Personalized mRNA Tumor Vaccine



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients Age 18 to 75 years old (including both ends)
  2. The primary lesion was confirmed by pathology or cytology as esophageal cancer and non-small cell lung cancer;
  3. Receive a biopsy before treatment;
  4. Patients with fertility must agree to use reliable methods of contraception (hormone or barrier or abstinence) during the trial and at least 12 weeks after the last treatment;
  5. The primary lesion was confirmed by pathology or cytology as esophageal cancer and non-small cell lung cancer;
  6. Patients with unresectable or metastatic esophageal cancer (IIIC (T4bNanyM0, TanyN3M0), stage IV) and non-small cell lung cancer (stage IIIB, IV) with standard treatment failure or no standard treatment;
  7. According to the solid tumor evaluation standard RECIST (version 1.1), at least one measurable tumor lesion (spiral CT scan tumor maximum diameter ≥ 10 mm);
  8. ECOG score 0~1;
  9. The number of lymphocytes is ≥800/μL, the number of absolute neutrophils is ≥1,500/μL, hemoglobin ≥10 g/dL; WBC≥2.5×109/L, PLT≥75×109/L, MID≥1.5×109/L, LY≥0.4×109/L; serum Alb≥30 g/L; serum lipase and amylase<1.5 ULN; serum creatinine≤1.5 ULN; ALT≤2.5 ULN, AST≤2.5 ULN, alkaline phosphatase ≤ 2.5 ULN; AST, ALT and alkaline phosphatase <5 ULN in the presence of bone or liver metastasis; serum urea nitrogen ≤ 3 ULN; serum total bilirubin ≤ 1.5 ULN; prothrombin time ( PT) extended ≤ 4s;
  10. Subjects volunteered to participate and signed informed consent in writing.

Exclusion Criteria:

1. Allergic constitution or a history of allergies to biopharmaceuticals; 2. Pregnant or lactating women; 4. The tumor mutation load (TMB) is less than 2.0/Mb or the tumor neonatal antigen load (TNB) is less than 0.5/Mb or the predicted number of nascent antigens is less than 3; 5. Patients with untreated brain metastases or symptoms of brain metastases (patients with stable brain metastases can be enrolled); 6. There are a wide range of tumor lung metastases, leading to difficulty breathing; 7. Patients with tumors close to large blood vessels or nerves; 8. History of severe cardiovascular and cerebrovascular diseases, including but not limited to ventricular arrhythmias requiring clinical intervention; acute coronary syndrome, myocardial infarction, congestive heart failure, stroke or other grade III and above within 6 months Cardiovascular events; New York Heart Association (NYHA) cardiac function classification ≥ II or left ventricular ejection fraction (LVEF) < 50%; hypertension still controlled by standard treatment (systolic blood pressure > 150 mmHg, diastolic blood pressure > 90 mmHg); 9. There are currently patients with active ulcers and gastrointestinal bleeding; 10. Patients with clinically diagnosed autoimmune diseases; HIV, HCV positive; HBsAg positive; those with acute EBV or CMV infection; 11. Patients with a history of organ transplantation or waiting for an organ transplant; 12. Any uncontrollable active person; 13. Subjects with immunosuppression, including known immunodeficiency; those currently on systemic use of steroids (except those who have recently or recently used inhaled steroids); 14. Skin diseases such as psoriasis may prevent intradermal injection of vaccine into the target area; 15. Anti-tumor treatments such as chemotherapy, biotherapy, radiation therapy, endocrine therapy, and targeted therapy were administered within 28 days prior to the first administration of mRNA tumor vaccine (in which fluorouracil oral drugs such as tigio, capecitabine, and finally One oral dose may be administered at least 14 days between the first dose of mRNA tumor vaccine, or other test drug treatment, or surgery (without diagnostic biopsy); 16. Adverse reactions to previous anti-tumor treatment have not been restored to CTCAE (version 4.03) grade evaluation ≤ 1 (except for hair loss); 17. The investigator assessed that the subject was unable or unwilling to comply with the requirements of the study protocol.

18. Previous chemotherapy, severe myelosuppression


Information from the National Library of Medicine

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


Contacts
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Contact: Li Yang 0371-66295320 yanglizzuyl@163.com
Contact: Yi Zhang 0371-66295219 yizhang001@163.com

Sponsors and Collaborators
Stemirna Therapeutics
The First Affiliated Hospital of Zhengzhou University
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Responsible Party: Stemirna Therapeutics
ClinicalTrials.gov Identifier: NCT03908671    
Other Study ID Numbers: STZD-1801
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 9, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stemirna Therapeutics:
mRNA cancer vaccine
cancer vaccine
tumor vaccine
NSCLC
Esophageal Cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Esophageal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases