Recurrent GlioblastomaEarly Phase 1NCT07538128
Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
A Early Phase 1 study testing YSCH-01 and Atezolizumab (1200 mg every three weeks) in people with Recurrent Glioblastoma, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Glioblastoma
- What is being tested?
- YSCH-01 and Atezolizumab (1200 mg every three weeks)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 9 Jan 2025to 28 Feb 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
Shan Jiang, +86-13661519863, jsscosmos@gmail.com
Zhifeng Shi, Dr.
About this study
Official title: 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
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
- Being tested
- YSCH-01, Atezolizumab (1200 mg every three weeks)
- Keywords
- YSCH-01, Recurrent Glioblastoma, Adenovirus, Atezolizumab
- Medical subject headings
- Glioblastoma, Adenoviridae Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YSCH-01Biological
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| YSCH-01 monotherapy | Experimental | Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir. Receives: 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. Receives: Biological: YSCH-01; Biological: Atezolizumab (1200 mg every three weeks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: One year after receiving the first dose of YSCH-01
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start9 Jan 2025
- Primary completion27 Nov 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GlioblastomaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Zhifeng Shi, Huashan Hospital
- Investigators
- Zhifeng Shi, Dr., Principal investigator, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07538128
- Sponsor's protocol ID
- KY2024-1142
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07538128
- Acronym / sponsor ID
- KY2024-1142
- Conditions
- Recurrent Glioblastoma
- Keywords
- YSCH-01, Recurrent Glioblastoma, Adenovirus, Atezolizumab
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Collaborators
- Shanghai Yuansong Biotechnology Co., Ltd.
- Study start
- 9 Jan 2025 (actual)
- Primary completion
- 27 Nov 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YSCH-01 monotherapy | Experimental | Biological: YSCH-01Participants will receive YSCH-01 monotherapy administered via intratumoral or intratumoral cavity injection through an implanted Ommaya reservoir. |
| YSCH-01 in combination with Atezolizumab | Experimental | Biological: YSCH-01, Biological: Atezolizumab (1200 mg every three weeks)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YSCH-01Participants 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. | Biological | YSCH-01 in combination with Atezolizumab, YSCH-01 monotherapy |
| Atezolizumab (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. | Biological | YSCH-01 in combination with Atezolizumab |
Primary outcome
Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhifeng Shi, Dr. principal investigator
Huashan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing YSCH-01 and Atezolizumab (1200 mg every three weeks) in people with Recurrent Glioblastoma, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shan Jiang, Dr. (+86 13661519863, jsscosmos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and Nature of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose up to 28 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.