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

ConditionRecurrent Glioblastoma

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorHuashan Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

YSCH-01
Biological/Vaccine
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/Vaccine
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.

Treatment groups

10 Participants

are divided into 2 treatment groups

Group A: YSCH-01 monotherapyExperimental treatment 1 intervention

Group B: YSCH-01 in combination with AtezolizumabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

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

Time frame

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)

Time frame

One year after receiving the first dose of YSCH-01

Sponsors and contacts

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Huashan Hospital

Lead sponsor

Shanghai Yuansong Biotechnology Co., LTD

Collaborator

Source ClinicalTrials.gov

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