Inhaled mRNA Tumor-associated Antigen Dry Powder Vaccine in Advanced Lung Cancer and Lung Metastasis of Solid Tumors.

Last updated: January 10, 2026
Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasm Metastasis

Treatment

BMD006 in combination with PD-1 antibody

BMD006 monotreatment

BMD006 in combination with PD-1/VEGF antibody

Clinical Study ID

NCT06928922
BMD006-001
  • Ages < 99
  • All Genders

Study Summary

BMD006 is an inhaled mRNA tumor-associated antigen dry powder vaccine targeting lung cancer and solid tumors with lung metastasis, classified as an off-the-shelf anti-tumor product. The product contains two clinically validated TAA antigen combinations: for patients with solid tumors that have lung metastasis, the mRNA vaccine consists of four mRNA sequences encoding melanoma-associated tumor antigens ; for patients with primary lung cancer, the mRNA vaccine consists of six mRNA sequences encoding tumor-associated antigens of primary lung cancer .

This study is a single-center, open-label, dose-escalation trial designed to evaluate the safety, tolerability, preliminary efficacy, PK, and PD of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have failed standard treatments or have no standard treatment options. Additionally, the study will further explore the effect of BMD006 in combination with PD-1 or Ivonescimab Injection treatment.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Able to understand and comply with the requirements of the study protocol,voluntarily participate in the trial, and sign a written informed consent form (ICF).

  • Must be at least 18 (inclusive) at the time of signing the ICF, and both male andfemale participants are eligible.

  • Histologically or cytologically confirmed as advanced lung cancer (driver genenegative) or advanced solid tumors with lung metastasis, and having failed priorstandard treatments or having no standard treatment options.

  • Agree to provide fresh tumor tissue samples or archived tumor tissue samples withinthe past three years.

  • Presence of at least one measurable lesion as defined by RECIST V1.1

  • Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1

  • Organ function must be adequate at screening (no need for blood transfusion,hematopoietic growth factors, human albumin, or medications for correction within 14days prior to first treatment), specifically defined as: a) Hematology: Absoluteneutrophil count ≥1.5×10^9/L; platelet count ≥90×10^9/L; hemoglobin ≥90 g/L (9g/dL). b) Liver Function: Serum total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); for patients with liver metastasis or a history/suspected history ofGilbert's syndrome (persistent or recurrent hyperbilirubinemia, primarilyunconjugated bilirubin, with no evidence of hemolysis or liver pathology), TBIL ≤3×ULN; for patients without liver metastasis, alanine aminotransferase (ALT) andaspartate aminotransferase (AST); for patients with liver metastasis, ALT or AST ≤5×ULN. c) Renal Function: Creatinine (Cr) ≤1.5×ULN or creatinine clearance (CLcr) ≥60 mL/min (calculated using the Cockcroft-Gault formula, see Attachment 3); urinedipstick test result showing urinary protein <2+; for patients with baseline urinedipstick showing protein ≥2+, a 24-hour urine collection should be conducted, andthe protein content in the 24-hour urine should be <1 g. d) Cardiac Function:Echocardiography showing left ventricular ejection fraction (LVEF) >50%. e)Pulmonary Function: Shortness of breath ≤Grade 1 as per the National CancerInstitute Common Terminology Criteria for Adverse Events (NCI CTCAE), and outdoorambient air oxygen saturation (SpO₂) ≥92%.

  • Expected life expectancy ≥12 weeks.

  • Female patients of childbearing potential and male patients (and their femalepartners) must use highly effective contraception from the screening period until atleast 6 months after the last dose of the study drug. Patients must not plan toconceive, donate sperm, or donate eggs during this period

Exclusion

Exclusion Criteria:

  • Patients with lung cancer who have concurrent other types of malignant tumors or arediagnosed with multiple primary malignancies, except for the following: completelyresected basal cell carcinoma and squamous cell carcinoma of the skin, completelyresected any type of carcinoma in situ.

  • Symptomatic central nervous system metastasis; for patients with asymptomatic brainmetastasis or those whose symptoms have been stable for ≥2 weeks after treatment ofbrain metastasis, they may participate in this study if they meet all the followingcriteria: measurable lesions in the lungs; cessation of steroid treatment 14 daysprior to the first trial product dose.

  • Patients with chronic obstructive pulmonary disease (COPD), asthma, or allergies topollen or dust.

  • Patients suspected of having active or latent tuberculosis infection, based oninterferon-γ release assay results, clinical symptoms, and/or chest imaging findings (patients with evidence of adequately treated prior active tuberculosis infectionmay be enrolled after assessment by the investigator; for latent tuberculosis,patients must have completed at least 4 weeks of anti-tuberculosis treatment, withno liver function impairment [ALT ≤3×ULN, AST ≤3×ULN], and after the investigatorassesses that the risk is manageable, they may be considered for continued screeningor enrollment).

  • History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis ororganizing pneumonia), or active, non-infectious pneumonia requiringimmunosuppressive treatment such as corticosteroids.

  • Patients with active autoimmune diseases requiring therapeutic intervention.

  • History of serious bleeding disorders; or those with coagulation dysfunction (asindicated by laboratory tests or medical history) who are deemed by the investigatorto be unsuitable for the trial treatment.

  • History or current diagnosis of cardiovascular disease, including any of thefollowing: a) Recent myocardial infarction or coronary artery bypass grafting (CABG)within the past 6 months; b) Uncontrolled congestive heart failure; c) Unstableangina (within the past 6 months); d) Clinically significant (symptomatic)arrhythmias (e.g., sustained ventricular tachycardia, clinically significant second-or third-degree atrioventricular block without a pacemaker).

  • Clinically uncontrolled third-space fluid accumulation (e.g., pleuraleffusion/pericardial effusion; patients with effusions that do not require drainageor those whose effusions have not increased significantly after stopping drainagefor 3 days may be included).

  • Severe infection requiring intravenous antibiotic treatment or hospitalization atscreening, or any uncontrolled active infection within 4 weeks prior to the firstdose of the trial product.

  • History of severe allergic reactions, or known allergy to any active or inactivecomponent of BMD006 or PD-1 inhibitors.

  • Any other metabolic, hematological, renal, hepatic, pulmonary, neurological,endocrine, cardiac, or gastrointestinal disease that, in the investigator's opinion,may present unacceptable risks to the patient during treatment.

  • Presence of unresolved toxicity from prior anti-tumor treatments before the firstdose of the study product, which has not recovered to Grade 0 or 1 (excludingalopecia) (severity assessed according to NCI CTCAE v5.0).

  • Positive test results for hepatitis B at screening [defined as: ① Hepatitis Bsurface antigen (HBsAg) positive; ② HBsAg negative but hepatitis B core antibody (HbcAb) positive (further testing through hepatitis B virus deoxyribonucleic acid [HBV DNA] is required, and patients with HBV DNA levels exceeding the normal limitfor the test method must be excluded)], positive hepatitis C antibody (HCV Ab) [further testing through hepatitis C virus ribonucleic acid (HCV RNA) is required,and patients with HCV RNA levels exceeding the normal limit for the test method mustbe excluded], or positive human immunodeficiency virus antibody (HIV Ab).

  • Underwent major surgery within 4 weeks prior to the first dose of the trial product (cranial, thoracic, or abdominal surgery) or has an unresolved wound, ulcer, orfracture. Note: Thoracoscopic surgery and mediastinoscopy will not be consideredmajor surgery. Patients who are ≥2 weeks post-surgery or who are deemed eligible bythe investigator may be included in the study.

  • Previously received similar products or treatments.

  • Received other anti-tumor treatments (radiotherapy, chemotherapy, endocrine therapy,targeted therapy, immunotherapy, etc.) within 4 weeks or 5 half-lives (whichever islonger) prior to the first dose of the trial product.

  • Received systemic immunosuppressive agents (e.g., systemic corticosteroids) within 3months prior to the first dose of the trial product.

  • Received or planned to receive live or attenuated live vaccines within 3 monthsprior to the first dose of the trial product or during the study.

  • Pregnant or breastfeeding women.

  • Participated in any clinical drug trial (defined as being randomized and receivingtrial product treatment) within 3 months or 5 half-lives (whichever is longer) priorto screening.

  • Any other condition deemed by the investigator to make the patient unsuitable forparticipation in the trial.

Study Design

Total Participants: 83
Treatment Group(s): 3
Primary Treatment: BMD006 in combination with PD-1 antibody
Phase: 1
Study Start date:
February 24, 2025
Estimated Completion Date:
February 24, 2028

Study Description

This study adopts a single center, open label, dose escalation design to evaluate the safety, tolerability, preliminary efficacy, PK and PD characteristics of BMD006 in patients with advanced lung cancer or advanced solid tumors with lung metastasis who have failed standard treatment or have no standard treatment, and to explore the treatment of BMD006 PD-1 or PD-1/VEGF.

This study includes three parts: exploring the dosage of BMD006 alone, exploring the dosage of BMD006 combined with PD-1 or PD-1/VEGF, and expanding the dosage of BMD006 combined with PD-1/VEGF.

Connect with a study center

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing,
    China

    Site Not Available

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing 1816670,
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.