Overview

Thymosin alpha-1 (Tα-1) has shown clinical benefits in patients whose immune functions are severely compromised or ineffective. Therefore, this study is attempted to explore whether Tα-1 could be used as a therapeutic option for the treatment of immune-related adverse events (irAEs).

Eligibility

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.