Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma

Официальное название

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

Обзор

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

Вмешательства

• Биопрепарат YSCH-01
  Participants will receive YSCH-01 monotherapy at a dose of 5.0 × 10¹⁰ VP every 3 weeks. YSCH-01 will be administered via intratumoral or intracavitary injection through an implanted Ommaya reservoir.
• Биопрепарат Atezolizumab (1200 mg every three weeks)
  Participants will receive YSCH-01 in combination with atezolizumab every 3 weeks. YSCH-01 will be administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir on Day 1 of each cycle at a dose of 5.0 × 10¹⁰ viral particles (VP). Atezolizumab (PD-L1 inhibitor) will be administered via intravenous infusion on Day 8 of each cycle at a dose of 1200 mg.

Первичные конечные точки

• Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: From first dose up to 28 days after last dose]
• 1-year survival rate [Срок оценки: One year after receiving the first dose of YSCH-01]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Huashan Hospital — Шанхай

Идентификаторы

NCT: NCT07538128 · KY2024-1142

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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