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

NCT07538128 | Recruiting Early Phase 1

• 1 other identifier: KY2024-1142
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Recurrent Glioblastoma

Keywords

YSCH-01; Recurrent Glioblastoma; Adenovirus; Atezolizumab

Outcome Measures

Primary Outcomes (2)

• Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Type, frequency, severity, and relationship to study treatment of AEs and SAEs assessed per NCI-CTCAE v5.0

  From first dose up to 28 days after last dose

• 1-year survival rate

  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)

  One year after receiving the first dose of YSCH-01

Study Arms (2)

YSCH-01 monotherapy

EXPERIMENTAL

Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir.

Biological: YSCH-01

YSCH-01 in combination with Atezolizumab

EXPERIMENTAL

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.

Biological: YSCH-01; Biological: Atezolizumab (1200 mg every three weeks)

Interventions

YSCH-01 BIOLOGICAL

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.

YSCH-01 in combination with Atezolizumab; YSCH-01 monotherapy

Atezolizumab (1200 mg every three weeks) BIOLOGICAL

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.

YSCH-01 in combination with Atezolizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead
• Shanghai Yuansong Biotechnology Co., LTD: collaborator

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Glioblastoma; Adenoviridae Infections

Interventions

atezolizumab

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Zhifeng Shi, Dr.

  Huashan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shan Jiang, Dr.

CONTACT

+86 13661519863; jsscosmos@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician, Associate Professor

Study Record Dates

• First Submitted: April 13, 2026
• First Posted: April 20, 2026
• Study Start: January 9, 2025
• Primary Completion (Estimated): November 27, 2026
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)