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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

A Clinical Trial Testing the Safety of the Investigational Drug Pumitamig (BNT327) and How Well it Works in Patients With Recurrent Glioblastoma (NCT07297212) is a Phase 2 interventional studying Recurrent Glioblastoma, sponsored by BioNTech SE. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Recurrent Glioblastoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 75 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Recurrent Glioblastoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Key Who May Qualify: - Adults, aged 18-75 years inclusive at the time of giving willing to sign a consent form. Local laws will be followed if the age at consent is older. - Have a diagnosed by tissue sample (biopsy-confirmed) diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria. - Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide. - Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. - Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria. - Have KPS ≥60. - Can swallow the medication and maintain oral administration. - Have a baseline brain MRI, not more than 14 days before starting the study treatment. - Have a stable dose of steroids ≥7 days before the contrast-enhanced scan. - Have your organs (liver, kidneys, etc.) are working well enough based on blood tests, as defined in the protocol. Key Who Should NOT Join This Trial: - Have received any of the following therapies or drugs before study enrollment: - Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment. - PD(L)-1/VEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof. - Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Key Inclusion Criteria: * Adults, aged 18-75 years inclusive at the time of giving informed consent. Local laws will be followed if the age at consent is older. * Have a histologically confirmed diagnosis of WHO Grade IV GBM, IDH-wildtype consistent with WHO CNS 2021 criteria. * Have recurrent supratentorial GBM who have received prior treatment with at least radiotherapy and temozolomide. * Have first recurrence documented by magnetic resonance imaging (MRI), with an interval of at least 12 weeks after the end of prior radiotherapy unless there is either: i) histopathologic confirmation of recurrent tumor, or ii) new enhancement on MRI outside of the radiotherapy treatment field. * Have been clinically evaluated as having relapsed or progressed disease with at least one measurable lesion as the targeted lesion based on RANO 2.0 criteria. * Have KPS ≥60. * Can swallow the medication and maintain oral administration. * Have a baseline brain MRI, not more than 14 days before starting the study treatment. * Have a stable dose of steroids ≥7 days before the contrast-enhanced scan. * Have adequate organ function, as defined in the protocol. Key Exclusion Criteria: * Have received any of the following therapies or drugs before study enrollment: * Any anticancer therapies, including systemic, palliative, biologic, immunostimulatory, or immunosuppressive treatment within 4 weeks (or five half-lives, whichever is longer) before starting the study treatment. * PD(L)-1/VEGF bispecific antibodies, cluster of differentiation (CD)137 agonists or other immune checkpoint blockade therapies including monotherapy with either category or combinations thereof. * Systemic corticosteroids (at a dosage greater than 2 mg/day of dexamethasone or an equivalent dose of other corticosteroids) within 7 days before starting the study treatment. * Vaccinations with live attenuated vaccine(s) within 4 weeks before starting the study treatment. * Broad-spectrum intravenous antibiotics therapy within 2 weeks before starting the study treatment. * Any non-study investigational medicinal product within five half-lives of the first dose or within 4 weeks, whichever is longer, before starting the study treatment in this study or ongoing participation in the active treatment phase of another interventional clinical study. * Antiplatelet drugs, such as aspirin (\>325 mg/day), clopidogrel (\>75 mg/day), dipyridamole, ticlopidine or cilostazol, etc., within 10 days before starting the study treatment to avoid inclusion of participants who have used platelet aggregation inhibitors before the study. * Have had more than one recurrence of GBM. * Are allergic to dacarbazine and temozolomide. * Have known leptomeningeal disease, extracranial disease, or multicentric disease. * Have been diagnosed with secondary GBM (i.e., glioblastomas that progress from low grade diffuse astrocytoma or anaplastic astrocytoma). * Have previously received radiotherapy with anything other than standard radiotherapy (i.e., focally directed radiation). * Have received prior interstitial brachytherapy, interstitial thermal therapy, implanted chemotherapy, or therapeutics delivered by local injection or convection-enhanced drug delivery. Participants who had prior treatment with Gliadel® wafers and who had concurrent use of devices such as Tumor Treating Fields are excluded. * Have uncontrolled hypertension or poorly controlled diabetic conditions as specified in the protocol before study enrollment. * Are unable (due to existent medical condition, e.g., pacemaker or implantable cardioverter defibrillator device) or unwilling to have a head contrast-enhanced MRI. * Have undergone major surgery, open biopsy, or significant traumatic injury within 28 days before starting the study treatment, or a planned/anticipated need for major surgery during the study treatment period. Placement of vascular infusion devices is allowed. Note: If participant has had major surgery, they must have recovered adequately from the toxicity and/or complications from the treatment prior to the initiation of study treatment. * Have received allogeneic hematopoietic stem cell transplantation or organ transplantation. * Have had other malignant tumors within 5 years before starting the study treatment. Exception: those who have been cured with local treatment (such as basal cell or squamous-cell carcinoma of the skin, superficial or noninvasive bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary carcinoma of thyroid and early-stage prostate cancer). * Have any of the following heart conditions within 6 months before starting the study treatment: * Myocardial infarction, unstable angina, acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, cerebrovascular accident or other Grade 3 and above cardiovascular events. * New York Heart Association functional classification ≥II heart failure or left ventricular ejection fraction \<50%. * Ventricular arrhythmias requiring clinical intervention, second- to third-degree atrioventricular block, or congenital long QT syndrome. Participants with stable treated cardiac arrythmia/atrial fibrillation are allowed. * Mean QTcF \>480 ms (the electrocardiogram can be repeated at the discretion of the investigator). * Cardiac troponin I or T \>2 × upper limit normal. * Have serious or non-healing wounds, ulcers, or (incompletely healed) bone fracture. This includes history (within 6 months before starting the study treatment) or risk of abdominal fistula, tracheoesophageal fistula, gastrointestinal perforation, or intra-abdominal abscess or esophageal and gastric varices, or acute gastrointestinal bleeding. In addition, the participant must have undergone correction (or spontaneous healing) of the perforation/fistula and/or the underlying process causing the fistula/perforation. * Have significant risk of hemorrhage (in the opinion of the investigator) or evidence of major coagulation disorders. * Have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). However, participants who are clinically stable following treatment for these conditions (including therapeutic thoracentesis or paracentesis or with indwelling catheters, e.g., PleurX) are allowed. * Have adverse events from prior antitumor therapy that have not returned to Grade 1 (graded by CTCAE v5.0 criteria) or below (unless the investigator determines that certain adverse events pose no safety risk to participants, such as hair loss or stable hypothyroidism under hormone replacement therapy). * Active colitis, including infectious, radioactive, ischemic enteritis, within 4 weeks before starting the study treatment. * History of serious allergic diseases, history of serious allergy to drugs (including unlisted investigational drug) or known allergy or intolerance to any ingredient of the study treatment. * Uncontrolled seizures after best medical therapy or other neurological conditions including clinically significant autoimmune neurological disorders which can increase risk for adverse effects or confound assessment of study outcomes as determined by the investigator. * Have superior vena cava syndrome or symptoms of spinal cord compression. * Have active, or a history of, pneumonitis requiring treatment with steroids, or have active or a history of interstitial lung disease. * Have a known history of tuberculosis that was not successfully treated. NOTE: Other protocol defined Inclusion/Exclusion criteria apply.

Treatments Being Tested

DRUG

Pumitamig

Intravenous (IV) infusion

DRUG

Bevacizumab

IV infusion

DRUG

Temozolomide

Oral

Locations (6)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07297212), the sponsor (BioNTech SE), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07297212 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07297212?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07297212?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07297212. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07297212. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.