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
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants with any of the following conditions are ineligible for enrollment:
- •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.
- •MRI evidence of tumor enhancement extending to the ventricular wall, or the tumor cavity is fused with the ventricle after surgery.
- •Preoperative MRI assessment showing the Ommaya puncture path traverses the ventricles.
- •Active infection requiring intravenous antibiotic therapy, or unexplained fever (body temperature ≥37.5°C).
- •Uncontrolled systemic diseases or relevant medical history, including: diabetes mellitus, cardiovascular/cerebrovascular disease (e.g., heart failure ≥NYHA Class II, hypertension ≥Grade 2, ≥First-degree atrioventricular block, history of myocardial infarction, myocarditis), pulmonary insufficiency, thyroid dysfunction, cerebral infarction within the past 6 months.
- •Active autoimmune disease or history of autoimmune disorders (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, autoimmune vasculitis, Wegener's granulomatosis).
- •Plan or requirement to receive any live vaccine during the screening or treatment phase.
- •Other conditions assessed as incompatible with intravenous administration of Atezolizumab.
研究组 & 干预措施
YSCH-01 in combination with Atezolizumab
Participants will receive YSCH-01 in combination with atezolizumab. YSCH-01 will be administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir, and atezolizumab will be administered intravenously.
干预措施: Atezolizumab (1200 mg every three weeks) (Biological)
YSCH-01 in combination with Atezolizumab
Participants will receive YSCH-01 in combination with atezolizumab. YSCH-01 will be administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir, and atezolizumab will be administered intravenously.
干预措施: YSCH-01 (Biological)
YSCH-01 monotherapy
Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir.
干预措施: YSCH-01 (Biological)
结局指标
主要结局
Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
时间窗: From first dose up to 28 days after last dose
Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0
1-year survival rate
时间窗: One year after receiving the first dose of YSCH-01
Defined as the proportion of participants who are alive at 1 year from the first dose of study intervention, referred to as 1-year Overall Survival (OS)
次要结局
未报告次要终点
研究者
Zhifeng Shi
Deputy Chief Physician, Associate Professor
Huashan Hospital