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

NCT07538128 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

BIOLOGICAL

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

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.

Sponsors & Collaborators

  • Shanghai Yuansong Biotechnology Co., LTD

    collaborator UNKNOWN

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Zhifeng Shi, Dr. · Huashan Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-09
Primary Completion
2026-11-27
Completion
2027-02-28

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07538128 on ClinicalTrials.gov