Actively Recruiting
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Led by BioNTech SE · Updated on 2026-04-29
75
Participants Needed
6
Research Sites
180 weeks
Total Duration
On this page
Sponsors
B
BioNTech SE
Lead Sponsor
B
Bristol-Myers Squibb
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years at the time of informed consent
- Histologically confirmed diagnosis of WHO Grade IV glioblastoma, IDH-wildtype per 2021 CNS criteria
- Recurrent supratentorial glioblastoma after prior treatment with radiotherapy and temozolomide
- First recurrence documented by MRI at least 12 weeks after prior radiotherapy unless confirmed by biopsy or new MRI findings outside radiotherapy field
- At least one measurable lesion based on RANO 2.0 criteria
- Karnofsky performance status of 60 or higher
- Able to swallow medication and maintain oral dosing
- Baseline brain MRI within 14 days before starting study treatment
- Stable steroid dose for at least 7 days before contrast-enhanced MRI
- Adequate organ function as defined in the study protocol
You will not qualify if you...
- Received any anticancer therapy within 4 weeks (or five half-lives, whichever longer) before starting study treatment
- Received PD(L)-1/VEGF bispecific antibodies, CD137 agonists, or other immune checkpoint blockade therapies
- Used systemic corticosteroids above 2 mg/day dexamethasone or equivalent within 7 days before study treatment
- Vaccinated with live attenuated vaccines within 4 weeks before study treatment
- Received broad-spectrum IV antibiotics within 2 weeks before study treatment
- Used investigational medicinal products within five half-lives or 4 weeks before study treatment
- Used antiplatelet drugs (aspirin >325 mg/day, clopidogrel >75 mg/day, others) within 10 days before study treatment
- More than one recurrence of glioblastoma
- Allergic to dacarbazine or temozolomide
- Known leptomeningeal, extracranial, or multicentric disease
- Diagnosed with secondary glioblastoma
- Prior radiotherapy other than standard focal radiation
- Prior interstitial brachytherapy, thermal therapy, implanted chemotherapy, or local drug delivery
- Uncontrolled hypertension or poorly controlled diabetes
- Unable or unwilling to undergo contrast-enhanced brain MRI
- Major surgery, open biopsy, or significant trauma within 28 days before study treatment
- History of allogeneic hematopoietic stem cell or organ transplantation
- Other malignant tumors within 5 years except certain cured local cancers
- Recent serious cardiovascular events or heart conditions within 6 months
- Serious or non-healing wounds, ulcers, or bone fractures
- Significant risk of bleeding or coagulation disorders
- Uncontrolled pleural, pericardial effusion, or ascites requiring frequent drainage
- Unresolved adverse events from prior antitumor therapy above Grade 1
- Active colitis within 4 weeks before study treatment
- History of serious allergic diseases or allergy to study treatment ingredients
- Uncontrolled seizures or significant neurological disorders
- Superior vena cava syndrome or spinal cord compression symptoms
- Active or history of pneumonitis or interstitial lung disease
- Untreated or unsuccessfully treated tuberculosis
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070
Actively Recruiting
2
Affiliated Tumor Hospital of Chongqing Medical University
Chongqing, China, 350209
Actively Recruiting
3
Affiliated Cancer Hospital of Shandong First Medical University
Jinan, China, 250117
Actively Recruiting
4
Huashan Hospital, Fudan University
Shanghai, China, 201107
Actively Recruiting
5
Shenzhen Second People's Hospital
Shenzhen, China, 518000
Actively Recruiting
6
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China, 430030
Actively Recruiting
Research Team
B
BioNTech clinical trials patient information
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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