RecruitingPhase 2NCT07297212

A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma

A Phase II, Multi-site, Open-label Trial Evaluating the Safety and Efficacy of Pumitamig and Bevacizumab as Monotherapy and Pumitamig in Combination With Temozolomide in Patients With Recurrent Glioblastoma


Sponsor

BioNTech SE

Enrollment

75 participants

Start Date

Jan 15, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This multi-site Phase II study will enroll adults with histologically confirmed diagnosis of World Health Organization (WHO) Grade IV glioblastoma (GBM), isocitrate dehydrogenase (IDH)-wildtype consistent with WHO central nervous system (CNS) 2021 criteria who have received prior first-line treatment including with at least radiotherapy and temozolomide, with a Karnofsky performance status (KPS) ≥60, adequate organ function, and at least one measurable lesion according to the response assessment in neuro-oncology (RANO) 2.0 criteria.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new immunotherapy drug called pumitamig (BNT327) in patients with glioblastoma — the most aggressive form of brain cancer — that has come back after initial treatment. **You may be eligible if...** - You are between 18 and 75 years old - You have a confirmed diagnosis of grade IV glioblastoma (IDH-wildtype) that has recurred - You have received standard treatment (radiation and temozolomide) previously - Your tumor is above the brain stem (supratentorial) - You are in good enough health to participate **You may NOT be eligible if...** - Your glioblastoma is in its first occurrence (not recurrent) - You have active autoimmune conditions requiring treatment - You have previously received immunotherapy for brain cancer - You have significant steroid requirements - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPumitamig

Intravenous (IV) infusion

DRUGBevacizumab

IV infusion

DRUGTemozolomide

Oral


Locations(6)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Affiliated Tumor Hospital of Chongqing Medical University

Chongqing, China

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, China

Huashan Hospital, Fudan University

Shanghai, China

Shenzhen Second People's Hospital

Shenzhen, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07297212


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