An Open-Label, Single-Center, Multiple-Dose Exploratory Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab in the Treatment of Recurrent Glioblastoma
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
⁃ Participants must meet all the following criteria to be enrolled in this study:
• 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.
• Presence of 1 contrast-enhancing tumor lesion (diameter 1-4 cm) assessed by MRI during the screening phase.
• Eligibility for tumor biopsy and Ommaya reservoir implantation based on hematological, hepatic, renal, and coagulation function parameters.
• Recovery from toxic effects of prior chemo/radiotherapy (CTCAE ≤ Grade 1, except for special cases like alopecia or pigmentation), with the Investigator determining that the corresponding adverse events (AEs) pose no safety risk.
• Eligible subjects of reproductive potential (male and female) must agree to use effective contraception during the trial and for at least 6 months after the last dose.