A Study of HF1K16 Combined With Bevacizumab in Patients With Recurrent or Progressive Glioma

Exclusion criteria

• . Any active autoimmune disease, or a history of autoimmune disease requiring systemic steroid therapy, with a daily prednisone dose \> 10 mg or equivalent corticosteroid within 2 weeks prior to study treatment.
• . Uncontrolled seizures, hypertension, or psychiatric disorder at screening.
• . Severe infection occurring within 4 weeks prior to the first dose, including but not limited to complicated infection requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose, except for antiviral therapy for hepatitis B or hepatitis C.
• . Third-space effusion that cannot be effectively controlled by drainage or other measures.
• . Participation in another clinical trial of an investigational drug within 4 weeks prior to enrollment.
• . Receipt of any anti-tumor therapy including chemotherapy, targeted therapy, biologic therapy, immunotherapy, radical radiotherapy, or major surgery within 2 weeks prior to enrollment or within 3 half-lives (whichever is shorter).
• . Any other active malignancy within 5 years prior to enrollment. Subjects with other malignancies cured by local therapy (e.g., basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix) are excepted.
• . Patients with hyperthyroidism are excluded. Subjects with hypothyroidism on a stable dose of thyroid hormone replacement therapy with stable thyroid function (TSH ≤ 10 μIU/mL and no clinical manifestations of hypothyroidism) may be enrolled.