YSCH-01 alone or with atezolizumab for recurrent glioblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, randomized early phase 1 trial enrolling 10 adults with recurrent glioblastoma who have a single contrast-enhancing lesion and meet safety criteria for biopsy and Ommaya reservoir placement. Participants are randomized 1:1 to receive YSCH-01 monotherapy or YSCH-01 plus intravenous atezolizumab (1200 mg every three weeks). The study includes screening, treatment, and follow-up phases, with the primary endpoint being one-year survival. Safety, tolerability, and preliminary signals of efficacy will be monitored closely in both cohorts.

Why it matters

Who can join: the full rules

Inclusion Criteria

Participants must meet all the following criteria to be enrolled in this study:

1. Age \> 18 years, male or female.
2. Expected survival ≥ 12 weeks.
3. Karnofsky Performance Status (KPS) score ≥ 70 at baseline.
4. Histopathologically confirmed glioblastoma (GBM), with first recurrence after prior surgery, chemotherapy, and/or radiotherapy.
5. Presence of 1 contrast-enhancing tumor lesion (diameter 1-4 cm) assessed by MRI during the screening phase.
6. Eligibility for tumor biopsy and Ommaya reservoir implantation based on hematological, hepatic, renal, and coagulation function parameters.
7. 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.
8. 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.

Exclusion Criteria

Participants with any of the following conditions are ineligible for enrollment:

1. History or current evidence of another primary malignancy.
2. Known allergy to the study drug or any of its excipients, or a history of unexplained severe allergic reactions.
3. Any contraindication to gadolinium-enhanced MRI, such as presence of a pacemaker, infusion pump, or allergy to MRI contrast agents.
4. Tumor involvement of the brainstem, cerebellum, or spinal cord; or leptomeningeal disease.
5. MRI evidence of tumor enhancement extending to the ventricular wall, or the tumor cavity is fused with the ventricle after surgery.
6. Preoperative MRI assessment showing the Ommaya puncture path traverses the ventricles.
7. Active infection requiring intravenous antibiotic therapy, or unexplained fever (body temperature ≥37.5°C).
8. 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.
9. 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).
10. Plan or requirement to receive any live vaccine during the screening or treatment phase.
11. Other conditions assessed as incompatible with intravenous administration of Atezolizumab.

Where it's running

• Huashan Hospital
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Zhifeng Shi, Dr. — Huashan Hospital
• Study coordinator: Shan Jiang, Dr.
• Email: jsscosmos@gmail.com
• Phone: +86 13661519863

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.