IL-22BP mRNA peptide therapy for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, single-arm, open-label, dose-escalation trial evaluating a peptide-based IL-22BP mRNA gene therapy delivered directly into tumors. The study uses a 3+3 design to test three fixed doses and assess safety, tolerability, and preliminary anti-tumor activity in patients with refractory advanced solid tumors. The investigational product aims to express IL-22BP within tumors to inhibit tumor progression, with a focus on biocompatibility and manufacturing simplicity compared with lipid nanoparticles. Preclinical data suggest an acceptable safety profile without major organ toxicity. Primary goal is safety/tolerability; secondary goal is early signs of anti-tumor activity.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female patients aged ≥18 years and ≤70 years.
* Histopathologically confirmed advanced recurrent/metastatic malignant solid tumors that are refractory to second-line treatment and have no available standard clinical therapeutic options (e.g., advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.).
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
* Expected overall survival ≥3 months.
* Interval from the last chemotherapy, radiotherapy, or surgery ≥28 days.
* Interval from the last use of nitrosourea or mitomycin C ≥6 weeks.
* Adequate organ function, defined by the following laboratory parameters within 14 days prior to enrollment:
* Hemoglobin ≥90 g/L (no blood transfusion within 14 days).
* Absolute neutrophil count \>1.5 × 10⁹/L.
* Platelet count ≥80 × 10⁹/L.
* Total bilirubin ≤1.5 × upper limit of normal (ULN).
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 × ULN (≤5 × -ULN in case of liver metastasis).
* Creatinine clearance ≥60 mL/min (calculated by Cockcroft-Gault formula).
* Left ventricular ejection fraction (LVEF) ≥50%.
* Signed written informed consent.

Exclusion Criteria:

* Participation in another investigational drug clinical trial within 4 weeks.
* Tumor located adjacent to major blood vessels or trachea.
* Uncontrolled cardiac clinical symptoms or diseases, including New York Heart Association (NYHA) Class ≥2 heart failure, unstable angina, myocardial infarction within 1 year, or clinically significant supraventricular/ventricular arrhythmias requiring treatment or intervention.
* Female patients who are pregnant or lactating.
* Active pulmonary tuberculosis, bacterial or fungal infection (≥Grade 2 per NCI-CTCAE version 5.0), active human immunodeficiency virus (HIV) infection, active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection.
* History of uncontrollable psychoactive substance abuse or presence of mental disorders.
* Any active autoimmune disease or history of autoimmune disease, including but not limited to uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism.
* Subjects with vitiligo or childhood asthma in complete remission (no adult intervention required) are eligible; subjects with asthma requiring bronchodilator therapy are excluded.
* Receiving immunosuppressive therapy.
* History of drug abuse or known medical, psychological, or social conditions that interfere with study compliance (e.g., alcoholism or illicit drug addiction).
* Known hypersensitivity, allergy, or intolerance to the study drug CPIL22BP mRNA (including any excipients), or history of severe allergic reactions to any drugs, foods, or vaccines (e.g., anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local Arthus reaction, etc.).
* Female subjects planning pregnancy, or male subjects whose partner plans pregnancy, from screening until 12 months after the last study drug injection.
* Any concomitant disease that, in the investigator's judgment, may seriously compromise patient safety or prevent the subject from completing the study.

Where it's running

• West China Hospital of Sichuan University
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Xingchen PXC Peng, Ph.D.
• Email: 13108175138@163.com
• Phone: 86+13108175138

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.