NCT07538128 Evaluating Safety, Tolerability, and Preliminary Efficacy of YSCH-01 Monotherapy and in Combination With Atezolizumab for Recurrent Glioblastoma
| NCT ID | NCT07538128 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Huashan Hospital |
| Condition | Recurrent Glioblastoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2025-01-09 |
| Primary Completion | 2026-11-27 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 10 participants in total. It began in 2025-01-09 with a primary completion date of 2026-11-27.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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.
Contact & Investigator
Zhifeng Shi, Dr.
PRINCIPAL INVESTIGATOR
Huashan Hospital
Frequently Asked Questions
Who can join the NCT07538128 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Recurrent Glioblastoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07538128 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07538128 currently recruiting?
Yes, NCT07538128 is actively recruiting participants. Contact the research team at jsscosmos@gmail.com for enrollment information.
Where is the NCT07538128 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07538128 clinical trial?
NCT07538128 is sponsored by Huashan Hospital. The principal investigator is Zhifeng Shi, Dr. at Huashan Hospital. The trial plans to enroll 10 participants.
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