The clinical study of YSCH-01 will adopt an open-label, randomized design, with a planned enrollment of 10 participants with recurrent glioblastoma. Participants will be randomly allocated to the YSCH-01 monotherapy cohort or the YSCH-01 + Atezolizumab combination cohort, with 5 participants in each cohort. The study consists of the following three phases: screening phase, treatment phase, and follow-up phase. The primary endpoint is the 1-year survival rate of participants
Age > 18 years, male or female.
Expected survival ≥ 12 weeks.
Karnofsky Performance Status (KPS) score ≥ 70 at baseline.
Histopathologically confirmed glioblastoma (GBM), with first recurrence after prior surgery, chemotherapy, and/or radiotherapy.
History or current evidence of another primary malignancy.
Known allergy to the study drug or any of its excipients, or a history of unexplained severe allergic reactions.
Any contraindication to gadolinium-enhanced MRI, such as presence of a pacemaker, infusion pump, or allergy to MRI contrast agents.
Tumor involvement of the brainstem, cerebellum, or spinal cord; or leptomeningeal disease.
Huashan Hospital
Lead sponsor
Shanghai Yuansong Biotechnology Co., LTD
Collaborator