Recurrent Glioblastoma
Conditions
Keywords
YSCH-01, Recurrent Glioblastoma, Adenovirus, Atezolizumab
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
Interventions
BIOLOGICALYSCH-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.
BIOLOGICALAtezolizumab (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.
Sponsors
Huashan Hospital
Shanghai Yuansong Biotechnology Co., LTD
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) | 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 | 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) |
Countries
China
Contacts
CONTACTShan Jiang, Dr.
PRINCIPAL_INVESTIGATORZhifeng Shi, Dr.
Huashan Hospital
Outcome results
None listed