Esophageal CancerNCT03908671
Clinical Study of Personalized mRNA Vaccine Encoding Neoantigen in Patients With Advanced Esophageal Cancer and Non-small Cell Lung Cancer
A study testing Personalized mRNA Tumor Vaccine in people with Esophageal Cancer and Non Small Cell Lung Cancer, run by Stemirna Therapeutics at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Personalized mRNA Tumor Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 18 Oct 2019to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged between 18 and 75 (including both ends), with no gender limit;
- The primary lesion was confirmed by histopathology or cytology as esophageal carcinoma (ⅢC (T4bNanyM0, TanyN3M0), and stage Ⅳ) or non-small cell lung cancer (stage ⅢB-Ⅳ).
- Patients who have metastatic or locally advanced tumor but failed instandard treatments or not suitable for standard treatments;
- According to RECIST (V1.1), the efficacy evaluation criteria for solid tumors, there is at least one measurable lesion.
- Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS
- Participants must have at least 1 lesion amenable to the mandatory fresh tumor biopsy at study entry
- Fertile patients must agree to use a reliable contraceptive methods (hormonal or barrier methods or abstinence) during the trial and for at least 12 weeks after the last treatment;
- The subject voluntarily participates and signs ICF (Informed consent forms).
Who cannot join
- Any clinical research drugs, anti-cancer monoclonal antibodies, anti-cancer therapeutic vaccines, immunostimulants (such as IL-2) or using previous investigational drugs within 7 days of the first treatment with mRNA-personalized tumor vaccine or carrelizumab.
- Patients who have allergies or previous history of biological drug allergy;
- Patients who are in pregnant or breast-feeding;
- Patients who are expected to survive less than 3 months during the screening period;
- Tumor mutation load (TMB) is less than 2.0/Mb or tumor neogenic antigen load (TNB) is less than 0.5/Mb or the number of predicted neoantigen is less than 3;
- Patients who underwent major surgery or suffered significant trauma within 4 weeks prior to the enrollment (blood collection), or who are expected to undergo major surgery during the study period;
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- Patients with symptoms of brain metastases (Patients with stable brain metastases can be included)
- Extensive lung metastases from tumors, causing breathing difficulties;
- Patients who have tumors close to large blood vessels or nerves;
- A history of severe cardiovascular and cerebrovascular diseases, including but not limited to ventricular arrhythmia requiring clinical intervention; Acute coronary syndrome, myocardial infarction, congestive heart failure, stroke or other grade III and above cardiovascular events within 6 months; New York Heart Association (NYHA) cardiac function grade≥Grade II or left ventricular ejection fraction (LVEF) <50%; Poorly controlled hypertension after standard treatment (systolic blood pressure> 150 mmHg and diastolic blood pressure> 90 mmHg);
- Patients with active ulcers and gastrointestinal bleeding;
- Patients with clinically confirmed autoimmune disease have received systemic treatment in the past 2 years; HIV, HCV positive; HBV-DNA≥1×103 copies/mL (or 2×102 IU/mL); Acute EBV or CMV virus infection;
- Patients with previous history of non-infectious pneumonia requiring steroid therapy or acute lung cancer;
- Participants with a history of interstitial lung disease;
- Patients who have a history of organ transplantation or are waiting for organ transplantation;
- Have any uncontrolled active infection;
- Immunosuppressed subjects, including those with known immunodeficiency; those who are currently using steroids systemically (except those who are using inhaled steroids recently or currently);
- Skin diseases (such as psoriasis) may prevent intradermal vaccines from reaching the target area;
- Who have received chemotherapy, biotherapy, radiotherapy, endocrine therapy, targeted therapy and other tumor treatments, or other experimental drug treatments, or surgery (excluding diagnostic biopsy) within 7 days prior to the first administration of mRNA tumor vaccine treatment;
- Adverse effects from previous antitumor therapy have not recovered referred to CTCAE (V5.0) rating ≤1 (except hair loss);
- The investigator evaluates that the subject is unable or unwilling to comply with the requirements of study protocol.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
Yi Zhang, Doctor, 15138928971, yizhang00@163.com
About this study
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
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
Read the 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).
- Conditions
- Esophageal Cancer, Non Small Cell Lung Cancer
- Being tested
- Personalized mRNA Tumor Vaccine
- Keywords
- mRNA cancer vaccine, cancer vaccine, tumor vaccine, NSCLC, Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized mRNA Tumor VaccineBiological
subcutaneous injection with personalized mRNA tumor vaccine
| Study group | Role | What they receive |
|---|---|---|
| Personalized mRNA Tumor Vaccine | Experimental | Personalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with advanced esophageal and non-small cell lung cancers Receives: Biological: Personalized mRNA Tumor Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
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
Measured: 24 weeks
Secondary outcomes (4)
Disease Control Rate (DCR)
Disease Control Rate of Personalized mRNA Tumor Vaccine
Measured: 1.5 years
Progression-free Survival (PFS)
Progression-free Survival of Personalized mRNA Tumor Vaccine
Measured: 2 years
Time to Tumor Progression (TTP)
Time to Tumor Progression of Personalized mRNA Tumor Vaccine
Measured: 2 years
Overall Survival (OS)
Overall Survival of Personalized mRNA Tumor Vaccine
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start18 Oct 2019
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stemirna Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03908671
- Sponsor's protocol ID
- STZD-1801
- Status last verified
- Apr 2023
- First submitted
- 8 Apr 2019
- Last updated
- 13 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03908671
- Acronym / sponsor ID
- STZD-1801
- Conditions
- Esophageal Cancer, Non Small Cell Lung Cancer
- Keywords
- mRNA cancer vaccine, cancer vaccine, tumor vaccine, NSCLC, Esophageal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Stemirna TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Zhengzhou University
- Study start
- 18 Oct 2019 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized mRNA Tumor Vaccine | Experimental | Biological: Personalized mRNA Tumor VaccinePersonalized mRNA Tumor Vaccine Encoding Neoantigen in Patients with advanced esophageal and non-small cell lung cancers |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Aged between 18 and 75 (including both ends), with no gender limit;
- The primary lesion was confirmed by histopathology or cytology as esophageal carcinoma (ⅢC (T4bNanyM0, TanyN3M0), and stage Ⅳ) or non-small cell lung cancer (stage ⅢB-Ⅳ).
- Patients who have metastatic or locally advanced tumor but failed instandard treatments or not suitable for standard treatments;
- According to RECIST (V1.1), the efficacy evaluation criteria for solid tumors, there is at least one measurable lesion.
- Participants with Performance Scale (PS) of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) PS
Key exclusion criteria (21 listed)
- Any clinical research drugs, anti-cancer monoclonal antibodies, anti-cancer therapeutic vaccines, immunostimulants (such as IL-2) or using previous investigational drugs within 7 days of the first treatment with mRNA-personalized tumor vaccine or carrelizumab.
- Patients who have allergies or previous history of biological drug allergy;
- Patients who are in pregnant or breast-feeding;
- Patients who are expected to survive less than 3 months during the screening period;
- Tumor mutation load (TMB) is less than 2.0/Mb or tumor neogenic antigen load (TNB) is less than 0.5/Mb or the number of predicted neoantigen is less than 3;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized mRNA Tumor Vaccinesubcutaneous injection with personalized mRNA tumor vaccine | Biological | Personalized mRNA Tumor Vaccine |
Primary outcome
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
4 secondary outcomes
Disease Control Rate (DCR)
Time frame: 1.5 years
Progression-free Survival (PFS)
Time frame: 2 years
Time to Tumor Progression (TTP)
Time frame: 2 years
Overall Survival (OS)
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized mRNA Tumor Vaccine in people with Esophageal Cancer and Non Small Cell Lung Cancer, run by Stemirna Therapeutics at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Yang (0371-66295320, yanglizzuyl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2023.