IL-22BP mRNA therapy for safety, tolerability, and anti-tumor effects in refractory solid tumors

A Clinical Trial Evaluating the Safety, Tolerability, and Preliminary Antitumor Activity of IL - 22BP in Refractory Malignant Solid Tumors.

Researchers will try an mRNA-delivered IL‑22BP treatment to see if it's safe and can shrink or slow tumors in adults with refractory metastatic solid tumors who have exhausted standard second-line options.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: West China Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 2 sites (Chengdu, Sichuan and 1 other locations)
• Trial ID: NCT07040943 on ClinicalTrials.gov

What this trial studies

This is a Phase 1 interventional trial of IL‑22BP delivered as an mRNA immunogene therapy in adults with advanced, refractory malignant solid tumors. The primary focus is on safety and tolerability with monitoring for any preliminary signs of anti-tumor activity. Eligible patients are adults 18–70 years old with histologically confirmed metastatic or recurrent solid tumors unresponsive to second-line therapy, ECOG 0–1, adequate organ function, and an expected survival of at least three months. Treatments and follow-up are conducted at West China Hospital in Chengdu, with outcomes including adverse events and measures of tumor response.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–70 with histologically confirmed metastatic or recurrent solid tumors refractory to second-line treatment, ECOG performance status 0–1, adequate organ function, and who can wait the required intervals since prior therapies and provide informed consent.

Not a fit: Patients whose tumors are adjacent to major blood vessels or the trachea, those with uncontrolled cardiac disease, recent participation in other drug trials, or who still have standard treatment options are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, this approach could offer a new treatment option that blocks IL‑22–driven tumor growth for patients with few remaining therapies.

How similar studies have performed: Preclinical data and broader mRNA immunotherapy work support the concept, but IL‑22BP mRNA therapy is novel and has not yet demonstrated clear clinical success in humans.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients: aged ≥ 18 years old and ≤ 70 years old;
2. Patients with histopathologically confirmed, refractory to second-line treatment, advanced recurrent/metastatic malignant solid tumors and without standard clinical treatment regimens (such as patients with advanced soft tissue sarcoma, advanced head and neck squamous cell carcinoma, malignant melanoma, etc.);
3. Eastern Cooperative Oncology Group (ECOG) performance status score: 0 - 1;
4. Expected survival time ≥ 3 months;
5. More than 28 days since the last chemotherapy/radiotherapy/surgery;
6. More than 6 weeks since the last use of nitrosoureas or mitomycin C;
7. Main organ functions are in good condition;
8. Sign a written informed consent form.

Exclusion Criteria:

1. Have participated in other drug clinical trials within 4 weeks;
2. The tumor is located close to major blood vessels or the trachea;
3. Patients with uncontrolled cardiac clinical symptoms or diseases, such as heart failure of NYHA class II or above, unstable angina pectoris, having had a myocardial infarction within 1 year, and having clinically significant supraventricular or ventricular arrhythmias that require treatment or intervention.
4. For female subjects: pregnant or lactating women.
5. Patients have active tuberculosis, bacterial or fungal infections (≥ grade 2 of NCI-CTCAE 5.0); have active HIV infection, active HBV infection, or HCV infection.
6. Those with a history of psychotropic drug abuse who are unable to quit or have mental disorders;
7. Subjects have any active autoimmune diseases or a history of autoimmune diseases (such as, but not limited to: uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or those whose asthma in childhood has been completely relieved and who do not require any intervention in adulthood can be included; subjects with asthma that requires bronchodilators for medical intervention cannot be included).
8. Subjects are currently receiving immunosuppressive treatment.
9. Have a history of drug abuse or known medical, psychological, or social conditions, such as a history of alcoholism or drug use.
10. Known to be allergic, hypersensitive, or intolerant to the studied IL-22BP (including any excipients). Have a severe allergy history to any drugs, foods, or vaccines in the past, such as anaphylactic shock, allergic laryngeal edema, allergic dyspnea, allergic purpura, thrombocytopenic purpura, local allergic necrotizing reaction (Arthus reaction), etc.
11. From the screening period to 12 months after the completion of drug injection, female subjects have pregnancy plans or the partners of male subjects have pregnancy plans.
12. According to the investigator's judgment, there are concomitant diseases that seriously endanger patient safety or affect the patient's completion of the study.

Where this trial is running

Chengdu, Sichuan and 1 other locations

• Department of Radiation Oncology — Chengdu, Sichuan, China (Recruiting)
• West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)

Study contacts

• Study coordinator: Xingchen Peng

Conditions Refractory Malignant Solid Tumors; mRNA Vaccine; Interleukin