About this trial
The primary purpose of this Phase II study is to evaluate the preliminary anti-tumor efficacy of HF1K16 in combination with Bevacizumab in patients with recurrent or progressive glioma. The study also evaluates the safety and tolerability of the combination therapy.
Eligibility criteria
Qualifiers
The patient and/or guardian must voluntarily sign and date a written informed consent form.
Age ≥ 18 years and ≤ 75 years at the time of informed consent signing, male or female.
Confirmed diagnosis of glioma by histopathology and molecular pathology, with recurrent or progressive disease following prior therapy, and no available standard treatment or intolerance to standard treatment.
Expected survival time of at least 3 months.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- HF1K16
Treatment groups
Locations
1Sponsors and collaborators
HighField Biopharmaceuticals Corporation
Lead sponsor