Using Thymosin Alpha-1 to treat immune-related side effects from cancer immunotherapy

A Prospective, Open, Randomized Controlled Stage II Trial Investigating the Efficacy and Safety of Thymosin Alpha-1 in Treating Moderate to Severe Immune-related Adverse Events

This study is testing if Thymosin Alpha-1 can help cancer patients who are having bad immune reactions from their treatment feel better while still using their regular medications.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Qianfoshan Hospital (other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06178146 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the use of Thymosin Alpha-1 (Tα-1) as a treatment for immune-related adverse events (irAEs) that occur in patients receiving immune checkpoint inhibitors for cancer. The study focuses on patients with malignant solid tumors who have developed significant irAEs within six months of therapy. Participants will receive Tα-1 alongside standard immunosuppressants to assess its effectiveness in managing these adverse effects. The trial aims to determine if Tα-1 can improve immune function and alleviate the severity of irAEs.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with malignant solid tumors who have developed Grade 2 to 4 irAEs after immune checkpoint inhibitor therapy.

Not a fit: Patients who do not have irAEs or those with Grade 1 adverse effects may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients experiencing severe immune-related side effects from cancer immunotherapy.

How similar studies have performed: Other studies have shown promising results using Thymosin Alpha-1 for immune-related conditions, suggesting potential efficacy in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Subjects who are males or females, aged 18 to 75 years;
2. Subjects who are willing to sign the informed consent forms and receive follow-up visits;
3. Subjects who are cytologically or histologically diagnosed with malignant solid tumors, including but not limited to genitourinary, gynecological, lung, liver, gastrointestinal tumors and melanoma;
4. Subjects with malignant solid tumors who have developed irAEs within 6 months of immune checkpoint inhibitor therapy (CTLA-4, PD-1 and/or PD-L1). The immune checkpoint inhibitors can be used alone, or combined with chemotherapy drugs or other ICIs;
5. Subjects with Grade 2 to 4 skin toxicity, enteritis, pneumonia and hepatitis secondary to ICIs according to CTCAE V5.0 and CSCO guidelines
6. Subjects with sufficient bone marrow functions and meet the following requirements:

(1) Hemoglobin level ≥ 90 g/L (2) Neutrophil count ≥ 1.0×10\^9/L (3) Lymphocyte count ≥ 0.5×10\^9/L (4) Platelet count ≥75×10\^9/L (5) PT, PTT, INR≤1.5 times ULN 7. Subjects with sufficient liver functions: Child-Pugh A and B; 8. Subjects with sufficient renal function: the estimated clearance rate calculated by the Cockroft-Gault formula is ≥40mL/min; 9. Suitable pregnant women who need to take effective contraceptive measures;

Exclusion Criteria:

1. Subjects who have ever immune-related adverse events due to ICI treatment;
2. Subjects who are diagnosed with immunodeficiency disease or are receiving systemic immunosuppressive therapy;
3. Subjects who have skin damage, liver damage, lung damage, etc. caused by the progression of malignant tumors;
4. Subjects who have the thromboembolic disease, biliary tract compression, perfusion injury, opportunistic infection, and liver injury caused by non-ICI drug reactions;
5. Subjects who have abnormal laboratory indicators caused by hepatotropic viruses (such as HAV, HBC, HCV) and non-hepatotropic viruses (such as Epstein-Barr virus, cytomegalovirus, and herpes simplex virus);
6. Subjects who are diagnosed with infectious colitis (e.g., caused by infections such as bacteria, Clostridium difficile, virus, fungus, parasite, etc.);
7. Subjects who suffer from autoimmune diseases, including but not limited to autoimmune hepatitis, primary cholangitis, primary sclerosing cholangitis, rheumatoid arthritis, vitiligo, psoriasis, Crohn's disease, type I diabetes, Grave's disease, etc.;
8. Subjects who suffer from other respiratory diseases with clear etiology, including malignant pulmonary infiltration, active infection, alternative systemic pulmonary toxicity or radiation pneumonitis;
9. Subjects with any other infectious diseases of grade 3 and above;
10. Subjects who have received and used thymosin products or other immunomodulators before enrollment;
11. Subjects who are allergic to thymosin products;
12. Pregnant or breastfeeding women;
13. Subjects who have any known bacterial, fungal or viral infections that may affect their safety or study compliance as deemed by the Investigator within 2 weeks before enrollment;
14. Subjects who have any health conditions that may prevent them from participating in and complying with the procedures related to the study as deemed by the Investigator, including additional laboratory abnormalities or mental illness.

Where this trial is running

Jinan, Shandong

• The first affiliated hospital of Shandong First Medical University — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Jun Wang, Professor — Shandong First Medical University
• Study coordinator: Jun Wang, Professor

Conditions: IrAE, immune-related adverse event, thymosin alpha 1