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| Name | Class |
|---|---|
| Shanghai Yuansong Biotechnology Co., LTD | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| YSCH-01 monotherapy | Experimental | Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria
Participants must meet all the following criteria to be enrolled in this study:
Exclusion Criteria
Participants with any of the following conditions are ineligible for enrollment:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shan Jiang, Dr. | Contact | +86 13661519863 | jsscosmos@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhifeng Shi, Dr. | Huashan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
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| 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. |
|
| ID | Term |
|---|---|
| D005909 | Glioblastoma |
| D000257 | Adenoviridae Infections |
| ID | Term |
|---|---|
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000594389 | atezolizumab |
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