YSCH-01 alone or with atezolizumab for recurrent glioblastoma

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

This will test whether YSCH-01 by itself or together with atezolizumab helps people with recurrent glioblastoma live longer.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Huashan Hospital (Academic / other)
• Drugs / interventions: Atezolizumab, chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07538128 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults over 18 with histologically confirmed recurrent glioblastoma after prior surgery/chemotherapy/radiation, a Karnofsky score ≥70, a single 1–4 cm contrast-enhancing lesion, and eligibility for tumor biopsy and Ommaya reservoir implantation.

Not a fit: Patients with multiple lesions, KPS below 70, expected survival under 12 weeks, or who cannot undergo biopsy/Ommaya placement are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the approach could increase one-year survival for some patients with recurrent glioblastoma compared with historical outcomes.

How similar studies have performed: Early-phase studies of oncolytic viral therapies combined with immune checkpoint inhibitors have shown promising signals in some brain-tumor patients but remain unproven in larger trials.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• Huashan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Principal investigator: Zhifeng Shi, Dr. — Huashan Hospital
• Study coordinator: Shan Jiang, Dr.

Conditions Recurrent Glioblastoma; YSCH-01; Adenovirus; Atezolizumab