Clinical Study on the Safety and Efficacy of TS-2021 in the Treatment of Recurrent Malignant Glioma

Inclusion Criteria:

• The patient signed the informed consent voluntarily.

• Age ≥18 years and ≤65 years, male or female.

• After the initial surgery, the imaging showed that the tumor was completely removed,followed by conventional radiotherapy or (and) chemotherapy, and no recurrence wasobserved within two months after the end of radiotherapy. The patient had arecurrence of supratentorial high-grade glioma. The pathological diagnosis wasglioblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplasticoligodendro-astrocytoma, or subtentorial astrocytoma recurrence.

• After conventional surgery, radiotherapy (or) chemotherapy was performed, and therewas no recurrence at the primary site of the tumor, but there was tumor recurrenceat the distant site.

• With PET/MRS, tumor recurrence was considered, and the enhanced lesion diameter wasgreater than 1cm, but less than 3cm.

• KPS score ≥70 before treatment.

• Normal bone marrow reserve function and normal liver and kidney function: Neutrophilabsolute value ≥ 1,500/mm3, hemoglobin ≥10 g/dL, platelet count ≥100,000/mm3, totalbilirubin level ≤1.5×ULN, glutamic pyruvic transaminase/glutamic oxalacetictransaminase ≤ 2.5× ULN, serum creatinine ≤1.5×ULN, The heart function was normaland the follow-up compliance was good.

• Women of childbearing age (15 to 49 years) must undergo a pregnancy test within 7days before starting treatment and the result is negative; Fertile men and womenmust consent to the use of effective contraception to ensure that they do not becomepregnant during the study period and for 3 months after stopping treatment.

Exclusion Criteria:

• Pregnant or lactating patients.

• Patients with encephalitis disease, multiple sclerosis, or other CNS (CentralNervous System) infection.

• Patients with a history of organ transplantation or waiting for organtransplantation.

• Patients with uncontrolled infectious diseases or other serious diseases, such asHIV positive.

• Patients with any unstable systemic illness (including active infection,uncontrolled hypertension, unstable angina pectoris, angina pectoris beginningwithin the last 3 months, congestive heart failure, myocardial infarction occurringwithin 12 months before enrollment, severe arrhythmia requiring medical treatment,liver or kidney failure, etc.)

• Patients with systemic autoimmune diseases or immunodeficiency diseases.

• Patients with severe allergic constitution.

• Patients with chronic diseases requiring long-term treatment with immune agents orglucocorticoids.

• Patients with mental disorders.