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AzTrials

NSCLCEarly Phase 1NCT06735508

MRNA Neoantigen Vaccine in Non-Small Cell Lung Cancer

A Early Phase 1 study testing mRNA Neoantigen Vaccine and Adebrelimab in people with NSCLC, run by Guangdong Provincial People's Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Brief Summary: This study is an open, prospective, exploratory clinical trial designed to evaluate the safety,ability, immunogenicity, and preliminary efficacy of a personalized neoantigen mRNA vaccine in combination with adebelimab as adjuvant treatment for patients with non-small cell lung cancer (NSCLC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
NSCLC
What is being tested?
mRNA Neoantigen Vaccine and Adebrelimab
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
Jan 2025to Dec 2026
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

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

  • Surgically resected and histologically or cytologically confirmed NSCLC according to the United States Joint Committee on Cancer (AJCC) eighth edition guidelines
  • Qualify and sufficient tumor samples for genetic testing and neoantigen analysis
  • There are no EGFR and ALK gene alteration
  • Eastern Cooperative Oncology Group (ECOG) score of United States: 0 or 1 point
  • Estimated survival ≥ 6 months
  • Qualify and sufficient blood samples for immunogenicity and biomarkers before and after treatment, of which the blood samples for genetic testing during the screening period must be free of blood transfusions, blood products and other hematopoietic stimulating factors within 7 days before collection
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  • Postoperative complications have recovered, or complications are lower than Clavien-Dindo complication grade 3
  • There was no evidence of disease in clinical examination, chest and abdomen contrast-enhanced CT and baseline radiological evaluation of head MRI within 14 days before the first dose
  • Female subjects of childbearing potential must have a serum pregnancy test within 7 days prior to the first dose with a negative result; and must be non-lactating
  • Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must agree to comply with contraceptive requirements from the time of signing the informed consent form until 90 days after the end of the last treatment (see "Contraceptive methods" in Annex V for details)

Who cannot join

  • Histologically or cytologically diagnosed small cell lung cancer (SCLC), or mixed tumors with small cell components, or neuroendocrine tumors or sarcomatoid carcinomas with large cell components
  • Any person who is not suitable for immunotherapy as assessed by the investigator
  • Presence of autoimmune diseases, except for hypothyroidism due to autoimmune thyroiditis that only requires hormone replacement therapy
  • Evidence of active tuberculosis infection within 1 year prior to initiation of study treatment, regardless of treatment
  • Subjects with a known history of interstitial pneumonia or a high suspicion of interstitial pneumonia, or evidence of active interstitial pneumonia on chest CT during the pre-screening period; Known history of idiopathic pulmonary fibrosis, history of organizing pneumonia (such as bronchiolitis obliterans or cryptogenic organizing pneumonia); and subjects who may interfere with the detection or management of suspected drug-related pulmonary toxicity
  • Severe infection (such as intravenous infusion of antibiotics, antifungal or antiviral drugs required according to clinical diagnosis and treatment standards) within 28 days before starting study treatment, or active infection that has received therapeutic intravenous or oral antibiotics within 14 days before starting study treatment
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  • Known allergy to the study drug or any of its excipients, or history of severe allergic reactions to other vaccines
  • Subject has a history of other malignancies within the past 5 years or at the same time, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin or squamous cell carcinoma of the skin, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection (hormonal therapy for non-metastatic prostate cancer or breast cancer is allowed), and papillary thyroid carcinoma
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
  • Patients with congenital or acquired immunodeficiency, such as cellular immunodeficiency (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SSCID]) or combined T-cell and B-cell immunodeficiency (e.g., T- and B-negative combined immunodeficiency, Wiskott-Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency); or human immunodeficiency virus (HIV) infection
  • Active hepatitis B (defined as a positive active hepatitis B virus surface antigen [HBsAg] test result during the screening period with detection of HBV DNA ≥500IU/mL or above the upper limit of normal for the study center), or hepatitis C (defined as a positive hepatitis C antibody [HCV-Ab] test result and HCV-RNA positive during the screening period)
  • Has poorly controlled or severe cardiovascular disease, such as severe/unstable angina, symptomatic congestive heart failure (NYHA Class III. or IV.), myocardial infarction within 6 months prior to initiation of study treatment, or unstable angina pectoris within 1 month prior to initiation of study treatment, or presence of cardiac arrhythmias requiring treatment or intervention, or poorly controlled hypertension (systolic blood pressure ≥ 150mmHg, diastolic blood pressure ≥90mmHg) after adequate treatment
  • In the opinion of the investigator, the subject has a history of other serious systemic diseases, or other reasons are not suitable for participating in this clinical study (such as any other disease that may affect the subject's compliance with the study treatment, interfere with the interpretation of the study results, or expose the subject to safety risks, or the tumor tissue sequencing data analysis results show that there are not enough neoantigens available for vaccine preparation, or the vaccine preparation fails); Other circumstances judged by the investigator that may affect the conduct of clinical research and the judgment of research results

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510000

    Wenzhao Zhong, MD

Other trials in China

About this study

Official title: An Exploratory Study of the Personalized MRNA Neoantigen Vaccine in Combination with Adebrelimab As Adjuvant Treatment for Patients with Resected Non-small Cell Lung Cancer

Brief Summary: This study is an open, prospective, exploratory clinical trial designed to evaluate the safety,ability, immunogenicity, and preliminary efficacy of a personalized neoantigen mRNA vaccine in combination with adebelimab as adjuvant treatment for patients with non-small cell lung cancer (NSCLC).

The primary objectives of this study are to answer the following key questions:

  1. The incidence of dose-limiting toxicities (DLTs) during the designated observation period.
  2. The incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
  3. The determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).
Conditions
NSCLC
Being tested
mRNA Neoantigen Vaccine, Adebrelimab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mRNA Neoantigen VaccineDrug

    mRNA Neoantigen Vaccine

  • AdebrelimabDrug

    Adebrelimab is a programmed death-ligand 1 antibody.

Study groups in NCT06735508
Study groupRoleWhat they receive
Arm AExperimentalSafe run-in phase and Dose Expansion phase
Receives: Drug: mRNA Neoantigen Vaccine; Drug: Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. safety and tolerability

    Percentage of subjects who meet the criteria of DLT in DLT observation period

    Measured: From the start of study treatments until 30 days after last dose of study treatments.

  2. MTD or MAD

    Determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended expansion dose (RDE) of mRNA Neoantigen in combination with adebelimab in the adjuvant treatment of resectable NSCLC after surgery

    Measured: From the start of study treatments until the end of the safety run-in phase, about 4 months.

Secondary outcomes (2)

  1. immunogenicity

    Change in immunogenicity compared to baseline, rate of the immune response

    Measured: From the sugery til the end of study treatment，about 18 months.

  2. Preliminary efficacy

    DFS rate and OS rate at 18 months/24 months.

    Measured: 3years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2024
  2. Study startJan 2025 (estimated)
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06735508
Sponsor's protocol ID
NSCLC-IIT-RGL
Status last verified
Nov 2024
First submitted
28 Nov 2024
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing mRNA Neoantigen Vaccine and Adebrelimab in people with NSCLC, run by Guangdong Provincial People's Hospital 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 16 Dec 2024. 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

safety and tolerability (time frame: From the start of study treatments until 30 days after last dose of study treatments.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06735508.

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 16 Dec 2024.

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