Personalized mRNA vaccine for advanced esophageal and 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

This study is testing a personalized mRNA vaccine to see if it can help people with advanced esophageal and lung cancer who haven't had success with other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Stemirna Therapeutics (Industry-sponsored)
• Drugs / interventions: carrelizumab, chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT03908671 on ClinicalTrials.gov

What this trial studies

This pilot study evaluates the safety, tolerability, and effectiveness of a personalized mRNA tumor vaccine that encodes neoantigens in patients with advanced esophageal cancer and non-small cell lung cancer (NSCLC) who have failed standard treatments or are not suitable for them. The study is open-label and single-arm, focusing on patients with unresectable or metastatic tumors. Primary objectives include assessing safety and tolerability, while secondary objectives involve preliminary efficacy observations, including tumor progression time and overall survival rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with advanced esophageal carcinoma or non-small cell lung cancer who have failed standard treatments.

Not a fit: Patients with early-stage cancers or those who have not yet undergone standard treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option for patients with advanced esophageal and lung cancers who have limited therapeutic alternatives.

How similar studies have performed: While personalized mRNA vaccines are a novel approach, similar studies have shown promising results in other cancer types, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Zhengzhou, Henan

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Study coordinator: Li Yang

Conditions Esophageal Cancer; Non Small Cell Lung Cancer; mRNA cancer vaccine; cancer vaccine; tumor vaccine; NSCLC