NCT07100210

A Clinical Trial Evaluating IL-22BP/LNP Compound in Refractory Malignant Solid Tumors for Safety, Tolerability and Activity

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Anti-tumor Activity of IL-22BP/LNP Compound in Refractory Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Xingchen Peng · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to investigate the safety and efficacy of the IL-22BP/LNP compound in patients with refractory malignant solid tumors, such as advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, and malignant melanoma, who have failed second-line treatment, have advanced recurrence or metastatic malignant solid tumors.

Detailed description

Cancer is a major cause of death among the global population and a significant obstacle to life extension. According to the statistics of the World Health Organization in 2019, it ranked as the first or second leading cause of death before the age of 70 in 112 countries, and in recent years, the burden of its incidence and mortality has increased rapidly. The treatment of advanced cancer consumes a large amount of resources, has poor efficacy, and is accompanied by numerous side effects. For example, the 5-year survival rate of advanced head and neck squamous cell carcinoma is only 40 - 50%, and radiotherapy may lead to osteonecrosis, while chemotherapy may cause hepatorenal toxicity and so on. Against this background, researchers have been exploring better treatment options, and gene therapy has attracted much attention. Messenger RNA (mRNA) is a crucial part of gene therapy, and immune gene therapy holds great potential. Interleukin-22 (IL-22) influences tumor development, and IL-22 binding protein (IL-22BP) can block its activity and impede the proliferation of tumor cells. Previously, there has been no research on mRNA vaccines targeting IL-22. Therefore, this project will provide a new treatment strategy for patients with advanced refractory malignant solid tumors.

Conditions

• Refractory Malignant Solid Tumors
• mRNA Vaccine
• Interleukin

Interventions

Type	Name	Description
BIOLOGICAL	IL-22BP mRNA vaccine injection	During the injection of IL-22BP/LNP compound, there were two dose groups, namely 25 μg and 50 μg of mRNA, with three participants in each dose group, aiming to evaluate the safety and tolerability of the IL-22BP/LNP compound formulation. The treatment will be administered by intratumoral injection. Enrolled subjects will receive inoculations of IL-22BP/LNP compound injection according to their respective dose groups, which include 5 doses for basic immunization and subsequent personalized treatment. During the basic immunization, the first 4 doses will be given at an interval of 1 week each, and the 5th dose will be administered 1 month after the 4th dose.The entire treatment period lasts for 2 months.

Timeline

• Start date: 2025-01-20
• Primary completion: 2026-02-20
• Completion: 2026-02-20
• First posted: 2025-08-03
• Last updated: 2025-12-29

Locations

1 site across 1 country: China