PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma.
NCT ID: NCT07053072
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
9 participants
INTERVENTIONAL
2025-10-23
2026-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
Three cases will be enrolled in each dose group, with the planned dose groups being the 50 μg, 75 μg and 100 μg groups. It consisted of 5 doses of basal immunisation and subsequent personalised treatment. For the base immunisation, the first 4 doses were administered 1 week apart each and the 5th dose was administered 1 month after the 4th dose.
Dose-limiting toxicity (DLT) will be monitored through a 21-day monitoring window. Escalation decisions will be made using a Bayesian Optimal Interval (BOIN) approach, with DLT classification following the
TREATMENT
NONE
Study Groups
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Low Dose
Low-dose PD-1 mRNA LNP vaccine for advanced primary hepatocellular carcinoma failing standard therapy
Low Dose PD-1 mRNA LNP Vaccine
Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Medium Dose
Medium Dose PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma Failing Standard Treatment
Medium dose PD-1 mRNA LNP vaccines
Patients will receive PD-1 mRNA LNP vaccine at 75 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
High Dose
High Dose PD-1 mRNA LNP Vaccine for Advanced Primary Hepatocellular Carcinoma Failing Standard Treatment
High dose PD-1 mRNA LNP vaccines
Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Interventions
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Low Dose PD-1 mRNA LNP Vaccine
Patients will receive PD-1 mRNA LNP vaccine at 50 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Medium dose PD-1 mRNA LNP vaccines
Patients will receive PD-1 mRNA LNP vaccine at 75 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
High dose PD-1 mRNA LNP vaccines
Patients will receive PD-1 mRNA LNP vaccine at 100 mcg weekly for the first 4 doses and a 5th dose 1 month after the 4th dose.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Recurrent or metastatic hepatocellular carcinoma that has failed second-line standard therapy.
3. Patients with at least one target lesion with a measurable diameter according to the RECIST criteria (CT scan of tumor lesions with a long diameter of ≥10mm, CT scan of lymph node lesions with a short diameter of ≥10mm and a layer thickness of no more than 5mm);
4. ECOG physical condition score: 0 to 1;
5. Expected survival ≥ 3 months;
6. Good function of major organs, i.e., relevant examination indexes within 14 days prior to randomization meet the following requirements:
* Routine blood tests: hemoglobin ≥80g/L (no blood transfusion within 14 days); neutrophil count \>1.5×109 /L; platelet count ≥80×109 /L;
* Biochemical tests: total bilirubin ≤1.5 × ULN (upper limit of normal); blood alanine aminotransferase (ALT) or blood alanine transaminase (AST) ≤ 2.5 × ULN; if liver metastases, ALT or AST ≤ 5 × ULN; endogenous creatinine clearance ≥ 60 ml/min (Cockcroft-Gault formula);
* cardiac Doppler ultrasound: left ventricular ejection fraction (LVEF) (LVEF) ≥50%.
7. Good compliance and family agreement to cooperate in receiving survival follow-up.
Exclusion Criteria
2. Patients with a prior history of other neoplasms, unless cervical cancer in situ, treated squamous skin cancer or epithelial tumor of the bladder or other malignancies that have undergone radical therapy (at least 5 years prior to enrollment);
3. Patients with uncontrolled cardiac clinical symptoms or disease, such as NYHA class 2 or higher heart failure, unstable angina pectoris , myocardial infarction within 1 year, clinically significant Supraventricular or ventricular arrhythmias requiring treatment or intervention.
4. For female subjects: women who are pregnant or breastfeeding.
5. Patients with active tuberculosis, bacterial or fungal infection (≥ grade 2 of NCI-CTCAE 5.0); HIV infection; active HBV infection; HCV infection.
6. Those with a history of psychotropic substance abuse that they are unable to abstain from or those with mental disorders;
7. Subjects with any active autoimmune disease or history of autoimmune disease (e.g., the following, but not limited to : uveitis, enteritis, pituitary gland inflammation, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma that has resolved completely in childhood and does not require any intervention in adulthood may be enrolled; subjects with asthma requiring medical intervention with bronchodilators may not be enrolled).
8. Patients who have been inoculated with mRNA drugs.
9. Participation in clinical trials involving lipid nanoparticles, a component of the study vaccine.
10. Contraindications to intramuscular injection.
11. History of substance abuse or known medical, psychological or social conditions such as alcohol or drug abuse.
12. Known allergy, hypersensitivity or intolerance to the investigational vaccine (including any excipients). Previous history of severe allergy to any drug, food, or vaccination, such as anaphylaxis, allergic laryngeal edema, allergic dyspnea, anaphylactic purpura, thrombocytopenic purpura, localized anaphylactic necrotic reaction (Arthus reaction).
13. The female subject is planning to become pregnant or the male subject's partner is planning to become pregnant during the Screening Period and up to 12 months after the full course of drug administration.
14. In the judgment of the investigator, there is a serious concomitant disease that jeopardizes the patient's safety or interferes with the patient's ability to complete the study.
18 Years
70 Years
ALL
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Xingchen Peng
PhD，professor
Principal Investigators
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Xingchen Peng
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Locations
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West China Hospital, Sichuan University
Chengdu, Sichuan, China
Sichuan University West China Hospital
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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References
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Chen X, Wu Y, Yang T, Wei M, Wang Y, Deng X, Shen C, Li W, Zhang H, Xu W, Gou L, Zeng Y, Zhang Y, Wang Z, Yang J. Salidroside alleviates cachexia symptoms in mouse models of cancer cachexia via activating mTOR signalling. J Cachexia Sarcopenia Muscle. 2016 May;7(2):225-32. doi: 10.1002/jcsm.12054. Epub 2016 Jan 18.
Wu Y, Li W, Chen X, Wang H, Su S, Xu Y, Deng X, Yang T, Wei M, Li L, Liu Y, Yang J, Li W. DOG1 as a novel antibody-drug conjugate target for the treatment of multiple gastrointestinal tumors and liver metastasis. Front Immunol. 2023 Jan 26;14:1051506. doi: 10.3389/fimmu.2023.1051506. eCollection 2023.
Sabnis S, Kumarasinghe ES, Salerno T, Mihai C, Ketova T, Senn JJ, Lynn A, Bulychev A, McFadyen I, Chan J, Almarsson O, Stanton MG, Benenato KE. A Novel Amino Lipid Series for mRNA Delivery: Improved Endosomal Escape and Sustained Pharmacology and Safety in Non-human Primates. Mol Ther. 2018 Jun 6;26(6):1509-1519. doi: 10.1016/j.ymthe.2018.03.010. Epub 2018 Mar 14.
Selvaggio G, Leonardelli L, Lofano G, Fresnay S, Parolo S, Medini D, Siena E, Marchetti L. A quantitative systems pharmacology approach to support mRNA vaccine development and optimization. CPT Pharmacometrics Syst Pharmacol. 2021 Dec;10(12):1448-1451. doi: 10.1002/psp4.12721. Epub 2021 Oct 21. No abstract available.
Xu S, Yang K, Li R, Zhang L. mRNA Vaccine Era-Mechanisms, Drug Platform and Clinical Prospection. Int J Mol Sci. 2020 Sep 9;21(18):6582. doi: 10.3390/ijms21186582.
Linares-Fernandez S, Lacroix C, Exposito JY, Verrier B. Tailoring mRNA Vaccine to Balance Innate/Adaptive Immune Response. Trends Mol Med. 2020 Mar;26(3):311-323. doi: 10.1016/j.molmed.2019.10.002. Epub 2019 Nov 5.
Verbeke R, Hogan MJ, Lore K, Pardi N. Innate immune mechanisms of mRNA vaccines. Immunity. 2022 Nov 8;55(11):1993-2005. doi: 10.1016/j.immuni.2022.10.014.
Lim SA, Cox A, Tung M, Chung EJ. Clinical progress of nanomedicine-based RNA therapies. Bioact Mater. 2021 Oct 22;12:203-213. doi: 10.1016/j.bioactmat.2021.10.018. eCollection 2022 Jun.
Sebastian M, Schroder A, Scheel B, Hong HS, Muth A, von Boehmer L, Zippelius A, Mayer F, Reck M, Atanackovic D, Thomas M, Schneller F, Stohlmacher J, Bernhard H, Groschel A, Lander T, Probst J, Strack T, Wiegand V, Gnad-Vogt U, Kallen KJ, Hoerr I, von der Muelbe F, Fotin-Mleczek M, Knuth A, Koch SD. A phase I/IIa study of the mRNA-based cancer immunotherapy CV9201 in patients with stage IIIB/IV non-small cell lung cancer. Cancer Immunol Immunother. 2019 May;68(5):799-812. doi: 10.1007/s00262-019-02315-x. Epub 2019 Feb 15.
Hong HS, Koch SD, Scheel B, Gnad-Vogt U, Schroder A, Kallen KJ, Wiegand V, Backert L, Kohlbacher O, Hoerr I, Fotin-Mleczek M, Billingsley JM. Distinct transcriptional changes in non-small cell lung cancer patients associated with multi-antigenic RNActive(R) CV9201 immunotherapy. Oncoimmunology. 2016 Nov 18;5(12):e1249560. doi: 10.1080/2162402X.2016.1249560. eCollection 2016.
Lorentzen CL, Haanen JB, Met O, Svane IM. Clinical advances and ongoing trials on mRNA vaccines for cancer treatment. Lancet Oncol. 2022 Oct;23(10):e450-e458. doi: 10.1016/S1470-2045(22)00372-2.
Yuan Y, Gao F, Chang Y, Zhao Q, He X. Advances of mRNA vaccine in tumor: a maze of opportunities and challenges. Biomark Res. 2023 Jan 18;11(1):6. doi: 10.1186/s40364-023-00449-w.
Miao L, Zhang Y, Huang L. mRNA vaccine for cancer immunotherapy. Mol Cancer. 2021 Feb 25;20(1):41. doi: 10.1186/s12943-021-01335-5.
Other Identifiers
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2025-755
Identifier Type: -
Identifier Source: org_study_id
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