Actively Recruiting
IMP3-saRNA Vaccine in Advanced NSCLC
Led by West China Hospital · Updated on 2026-05-12
9
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, single-arm, non-randomized, single-center, prospective phase 1 clinical trial. The study will evaluate the safety, tolerability, and preliminary antitumor activity of IMP3-saRNA (YMN-136) vaccine in patients with advanced non-small cell lung cancer. IMP3-saRNA (YMN-136) is a vaccine product prepared from IMP3 self-amplifying RNA and lipid nanoparticles. The study will enroll patients with histologically or cytologically confirmed non-small cell lung cancer who have failed standard treatment, are intolerant to standard treatment, or have refused standard treatment, and whose tumor tissue is positive for IMP3 expression. A total of 9 participants are planned to be enrolled. Participants will enter one of three dose groups sequentially: 50 micrograms, 100 micrograms, or 200 micrograms. Each dose group will include 3 participants. The study will use a 3+3 dose-escalation design. The vaccine will be administered by intramuscular injection. The immunization schedule includes 4 doses, with each dose given 3 weeks apart. The main purpose of the study is to assess safety and tolerability. Dose-limiting toxicity will be assessed from the first vaccination until 14 days after the third vaccination. Safety assessments will include adverse events, serious adverse events, physical examinations, vital signs, ECOG performance status, laboratory tests, 12-lead electrocardiogram, and echocardiography. The study will also preliminarily assess antitumor activity using RECIST version 1.1. Imaging assessments may include CT or MRI and whole-body bone scan. Additional exploratory evaluations may include blood and tumor tissue biomarker analyses, such as ctDNA, tumor markers, immune cell subsets, dendritic cell maturation, antigen-specific cytotoxic T cells, T-cell activation, antibody titers, PD-L1 expression, gene mutation analysis, and other immune-related tests.
CONDITIONS
Official Title
IMP3-saRNA Vaccine in Advanced NSCLC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older who have signed informed consent.
- Histologically or cytologically confirmed non-small cell lung cancer with IMP3-positive tumor tissue.
- Have failed, are intolerant to, or have refused standard treatments.
- At least one measurable or evaluable lesion according to RECIST version 1.1.
- ECOG performance status score of 0 to 2.
- Estimated life expectancy of at least 3 months.
- Adequate major organ function based on specific laboratory values within 7 days before treatment.
- Male and female patients with reproductive potential agree to effective contraception during the study and specified post-treatment periods.
- Washout periods of at least 4 weeks for prior antitumor therapy and specific timelines for targeted therapies, radiotherapy, and major surgery.
You will not qualify if you...
- History of other malignancies except certain cured or non-recurrent cancers within 5 years.
- Uncontrolled clinical diseases or major psychiatric disorders that could interfere with study participation.
- Active autoimmune diseases or history of autoimmune disease except controlled type 1 diabetes; asthma requiring medical intervention is excluded.
- Active central nervous system metastases unless recovered for at least 2 weeks and off corticosteroids for 4 weeks.
- Allergy to the study drug or severe allergies such as anaphylaxis.
- Contraindications to injection including inflammation or trauma at the injection site.
- Prior organ or stem cell transplantation.
- Prior antitumor vaccine or cellular immunotherapy.
- Participation in another clinical trial within 4 weeks before screening.
- Major surgery within 4 weeks before first vaccination except minor procedures.
- Recent use of systemic corticosteroids or immunosuppressive agents exceeding specified doses.
- Unresolved toxicity from prior antitumor therapy except specific exceptions.
- Known infections including hepatitis B, C, HIV, or syphilis with specified criteria.
- Active tuberculosis or severe infections requiring systemic treatment.
- History of drug abuse or significant medical, psychological, or social conditions.
- Pregnant or breastfeeding women or those planning pregnancy during and up to 12 months post-treatment.
- Receipt of any vaccine within 30 days before study vaccine or planned vaccines during study.
- History of deep vein thrombosis or pulmonary embolism within 6 months.
- Uncontrolled infections requiring antibiotics except simple urinary or pharyngitis after consultation.
- History or presence of central nervous system diseases like seizures or dementia.
- Significant immunodeficiency.
- Negative or unconfirmed IMP3 tumor test.
- Any other factors judged unsuitable by the investigator.
- Inability or unwillingness to comply with study requirements.
AI-Screening
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Trial Site Locations
Total: 1 location
1
West China Hospital, Sichuan University, Chengdu, Sichuan
Chengdu, Sichuan, China, 610041
Actively Recruiting
Research Team
X
Xingchen Peng, Professor
CONTACT
Z
Ziyu Xu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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