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GlioblastomaPhase 1NCT05938387

Safety and Tolerability of CVGBM in Adults With Newly Diagnosed MGMT-Unmethylated Glioblastoma or Astrocytoma

A Phase 1 study testing CV09050101 mRNA vaccine (CVGBM) 12 μg, CV09050101 mRNA vaccine (CVGBM) 25 μg and CV09050101 mRNA vaccine (CVGBM) 50 μg in people with Glioblastoma, run by CureVac at 13 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Glioblastoma
What is being tested?
CV09050101 mRNA vaccine (CVGBM) 12 μg, CV09050101 mRNA vaccine (CVGBM) 25 μg and CV09050101 mRNA vaccine (CVGBM) 50 μg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
13 sitesin 3 countries
Study dates
1 Jun 2023to 2 Feb 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed, newly diagnosed GBM (CNS WHO Grade 4) and IDH-wildtype astrocytoma with a molecular signature of "unmethylated" GBM.
  • Specific HLA genotype.
  • Gross total or partial resection (i.e., ≥50% of tumor volume resected).
  • Having completed radiotherapy with or without chemotherapy post-surgery at least 2 weeks before study treatment initiation with no signs of disease progression. Patients must have recovered from any radiotherapy or chemotherapy related side effects to ≤ Grade 1 (with the exception of ALC and WBC as per eligibility criteria). Pretreatment (and concomitant treatment) with TTFields therapy for GBM is allowed.
  • Age ≥18 years.
  • Karnofsky Performance Status (KPS) ≥70%.
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  • Life expectancy >6 months.
  • Absolute lymphocyte count (ALC) >0.5 x109/L.
  • Each patient must voluntarily sign and date an informed consent form (ICF) approved by an Independent Ethics Committee (IEC), prior to the initiation of any pre-screening, screening or study-specific procedures. Note: Patients will sign a separate ICF to allow pre-screening/HLA genotyping.
  • Female patients who are post-menopausal (no menses for at least 12 months before the Screening Visit), or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy).
  • Females of childbearing potential must:
  • Have a negative serum pregnancy test with a sensitivity of at least 25 mIU/mL within 10 to 14 days, and within 24 hours prior to starting the study treatment a negative urine pregnancy test.
  • Agree to ongoing pregnancy testing during the study.
  • Use effective contraception at least 28 days before starting study treatment through to 30 days after the last dose of study treatment. Effective methods of birth control include:
  • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation:
  • oral
  • intravaginal
  • transdermal
  • progestogen-only hormonal contraception associated with inhibition of ovulation:
  • oral
  • injectable
  • implantable
  • intrauterine device
  • intrauterine hormone-releasing system
  • bilateral tubal occlusion
  • vasectomised partner + barrier method
  • sexual abstinence: Either agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and lactational amenorrhoea method (LAM) are not acceptable methods of contraception.
  • Male patients, even if surgically sterilized (i.e., status postvasectomy), must:
  • Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal (coitus interruptus), spermicides only and LAM are not acceptable methods of contraception.
  • Agree to practice effective barrier contraception during the entire study treatment period (e.g., condom) and through to 3 months after the last dose of study treatment if their partner is of childbearing potential, even if they have had a successful vasectomy.

Who cannot join

  • Abnormal (≥Grade 2 NCI-CTCAE v5.0) laboratory values for hematology, liver and renal function (serum creatinine). The following values apply as exclusion criteria:
  • Hemoglobin <10 g/dL (6.2 mmol/L)
  • White blood cell (WBC) count decrease (<2.5 x109/L)
  • Absolute neutrophil count (ANC) decrease <1.5 x109/L
  • Platelet count decrease <75 x109/L
  • Bilirubin >1.5 x upper limit of normal (ULN according to the performing lab's reference range), except for patients with Gilbert's syndrome
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  • Alanine aminotransferase (ALT) >3 x ULN
  • Aspartate aminotransferase (AST) >3 x ULN
  • Gamma glutamyltransferase (GGT) >2.5 x ULN
  • Serum creatinine increased >1.5 x ULN
  • Tumor biopsy only without gross total or partial resection (i.e., ≥50% of tumor volume resected).
  • Any prior therapy for GBM (except surgery, radiotherapy with or without chemotherapy (e.g., temozolomide [TMZ]), TTFields, and steroids) including immunotherapy.
  • Patient on stable or decreasing steroid levels exceeding 10 mg/day prednisone (or equivalent doses of other steroids) during the last 3 days prior to enrollment. Expectation that the patient will need steroid doses >10 mg/day prednisone or equivalent during the next 3 months. Note: Steroid treatment during the study will be allowed for treatment of cerebral edema or other life-threatening conditions.
  • Active human immunodeficiency virus (HIV) infection (ie, CD4 count below the normal range) or active Hepatitis B or C infection (i.e., detectable levels of Hepatitis B DNA or Hepatitis C RNA), or active infections requiring oral or intravenous antibiotics or that can cause a severe disease.
  • Clinically relevant autoimmune diseases that could impact the assessment of vaccine safety and efficacy (with the exception of clinically stable thyroid diseases under medication and vitiligo).
  • Immunosuppression, not related to prior treatment for malignancy. Any medical condition that requires chronic systemic immunosuppressive therapy including chronic corticosteroids (except physiologic maintenance/replacement doses), methotrexate, tacrolimus or any other immunosuppressive agents within 28 days of treatment start, including, but not limited, to organ transplant-related immunosuppression.
  • Patients with prior hematopoietic stem cell transplantation/prior organ allograft.
  • Any condition that in the judgment of the Investigator is likely to prevent compliance with study procedures.
  • Patients with impaired coagulation or any bleeding disorder in whom an intramuscular injection or blood draw is contraindicated.
  • History of myocarditis or pericarditis within the last 3 months or history of myocarditis or pericarditis following COVID-19 vaccination.
  • Previous mRNA vaccination (e.g., SARS-CoV2) or live attenuated vaccination within 1 month prior to study treatment initiation, other vaccines within 2 weeks prior to study treatment initiation.
  • Serious illness or condition, which according to the Investigator poses an undue risk for the patient when participating in the trial, including, but not limited to, any of the following:
  • Clinically significant cardiovascular disease (myocardial infarction or stroke within last 6 months, uncontrolled angina within last 3 months, diagnosed or suspected clinically significant ventricular arrhythmias, ejection fraction <35%, cerebrovascular event within last 6 months, uncontrolled hypertension [blood pressure ≥180 mm Hg systolic and 110 mmHg diastolic despite medication])
  • New York Heart Association Class III to IV congestive heart failure
  • Symptomatic peripheral vascular disease
  • Severe pulmonary disease (e.g., severe chronic obstructive pulmonary disease, pneumonitis or interstitial lung disease)
  • Uncontrolled diabetes (repeated episodes of severe hypo- or hyperglycemia requiring hospitalization)
  • Severe mental retardation/impairment, psychiatric conditions or substance abuse resulting in inability to understand informed consent or affecting the patient's cooperation in the study
  • Severe infection/inflammatory conditions
  • History of other malignancies (except for those which have been adequately treated and have had no recurrence).
  • Previous anaphylactic or severe allergic reaction to an LNP formulated drug or vaccine (e.g., Comirnaty or Spikevax) or known allergy to any other component of CVGBM (e.g., PEG).
  • Allergy to aminoglycoside antibiotics.
  • Pregnant or breastfeeding.
  • Prior (within 30 days prior to study enrollment) or concurrent participation in another interventional clinical trial studying an investigational product, drug or treatment regimen. At least 30 days should have passed prior to the first study treatment with the investigational product (exceptions may be considered on a case-by-case basis after consultation with the CureVac Medical Director).

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Germany10 sites

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia

  • University Hospital Essen

    Essen, North Rhine-Westphalia

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg

  • University Clinic Heidelberg

    Heidelberg, Baden-Wurttemberg

  • Universitatsklinikum Leipzig

    Leipzig, Saxony

  • Universitätsmedizin Mannheim

    Mannheim, Baden-Wurttemberg

  • Neurosurgical Clinic at the LMU Munich

    München

  • University Clinic Regensburg

    Regensburg, Bavaria

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg

Other trials in Germany

Belgium2 sites

  • Universitair Ziekenhuis Brussel - PPDS

    Brussels

  • CHU de Liège

    Liège

Other trials in Belgium

Netherlands1 site

  • Erasmusmc Cancer institute

    Rotterdam, South Holland

Other trials in Netherlands

About this study

Official title: A Phase 1 Dose-Finding Study to Evaluate Safety and Tolerability of CVGBM in Patients With Surgically Resected Glioblastoma (GBM) or Astrocytoma With a Molecular Signature of Unmethylated Glioblastoma

This study is an open-label, first-in-human, dose-escalation study of CV09050101 mRNA vaccine (CVGBM) in patients with newly diagnosed "MGMT-unmethylated" Glioblastoma (GBM). Patients with isocitrate dehydrogenase (IDH)-wildtype astrocytoma with a molecular signature of "unmethylated" GBM are also eligible.

After surgical resection and completion of radiotherapy for GBM with or without chemotherapy, patients will receive CVGBM i.e. as monotherapy after radiotherapy with or without chemotherapy.

Read more

The study consists of a dose-escalation part (Part A) which completes enrollment in February 2024 and a dose-expansion part (Part B) which is anticipated to begin enrolling in June/July 2024.

Patients will receive a total of 7 administrations of CVGBM on Days 1, 8, 15, 29, 43, 57, and 71. At the discretion of the Investigator in alignment with the Sponsor's medical monitor the vaccinations may continue beyond Day 71 every 6 weeks until one year after the first CVGBM vaccination or upon disease progression or undue toxicity.

Conditions
Glioblastoma
Being tested
CV09050101 mRNA vaccine (CVGBM) 12 μg, CV09050101 mRNA vaccine (CVGBM) 25 μg, CV09050101 mRNA vaccine (CVGBM) 50 μg, CV09050101 mRNA vaccine (CVGBM) 100 μg, CV09050101 mRNA vaccine RDE 100 μg
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CV09050101 mRNA vaccine (CVGBM) 12 μgBiological

    CVGBM will be administered as an IM injection.

  • CV09050101 mRNA vaccine (CVGBM) 25 μgBiological

    CVGBM will be administered as an IM injection.

  • CV09050101 mRNA vaccine (CVGBM) 50 μgBiological

    CVGBM will be administered as an IM injection.

  • CV09050101 mRNA vaccine (CVGBM) 100 μgBiological

    CVGBM will be administered as an IM injection.

  • CV09050101 mRNA vaccine RDE 100 μgBiological

    CVGBM will be administered as an IM injection.

  • CV09050101 mRNA vaccine (CVGBM) 6 μgBiological

    CVGBM will be administered as an IM injection.

Study groups in NCT05938387
Study groupRoleWhat they receive
Dose escalation: CVGBM Dose Level -1ExperimentalDose Level -1 represents a dose that may be evaluated if dose level 1 is poorly tolerated. No dose de-escalation below this level is planned for this study. If the dose level -1 is poorly tolerated, the study will be terminated.
Receives: Biological: CV09050101 mRNA vaccine (CVGBM) 6 μg
Dose escalation: CVGBM Dose Level 1ExperimentalNot described
Receives: Biological: CV09050101 mRNA vaccine (CVGBM) 12 μg
Dose escalation: CVGBM Dose Level 2ExperimentalNot described
Receives: Biological: CV09050101 mRNA vaccine (CVGBM) 25 μg
Dose escalation: CVGBM Dose Level 3ExperimentalNot described
Receives: Biological: CV09050101 mRNA vaccine (CVGBM) 50 μg
Dose escalation: CVGBM Dose Level 4ExperimentalNot described
Receives: Biological: CV09050101 mRNA vaccine (CVGBM) 100 μg
Dose expansionExperimentalAfter completion of the dose-escalation part and safety data review by the DSMB, approximately 20 patients will be enrolled at the selected Recommended Dose for Expansion (RDE) to generate more data on safety, tolerability and immunogenicity.
Receives: Biological: CV09050101 mRNA vaccine RDE 100 μg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related adverse events (TRAEs)

    Measured: 1 year

  2. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: 1 year

  3. Incidence of serious adverse events (SAEs)

    Measured: 1 year

  4. Incidence of immune related adverse events (irAEs)

    Measured: 1 year

  5. Incidence of injection site reactions (ISRs)

    Measured: 1 year

  6. Incidence of clinically significant laboratory abnormalities per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v.5.0

    Measured: 1 year

  7. Incidence dose-limiting toxicities (DLTs)

    Measured: Through the first 2 weeks of treatment

  8. Severity of DLTs (Unit: Grading via NCI-CTCAE v5.0)

    Measured: Through the first 2 weeks of treatment

Secondary outcomes (4)

  1. Time to relapse from the day of surgery until the last scheduled visit of the study

    Measured: 1 year

  2. Progression-Free Survival (PFS) rate from the day of surgery until the last scheduled visit of the study

    Measured: 1 year

  3. Overall survival (OS) rate from the day of surgery until the last scheduled visit of the study

    Measured: 1 year

  4. Change in the patients' quality of life measured using a patient-reported-outcome questionnaire

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2023
  2. Study start1 Jun 2023
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05938387
Sponsor's protocol ID
CV-GBLM-001
Other IDs
2022-501423-25
Status last verified
Feb 2026
First submitted
6 Jun 2023
Last updated
18 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lutz J, Feist RK, Sonntag T, Peguero-Sanchez E, Wolter K, Bick R, Bauer J, Walz JS, Heidenreich R. Preclinical development of an mRNA-based multiepitope immunotherapeutic for glioblastoma. Cancer Immunol Immunother. 2025 Oct 6;74(11):329. doi: 10.1007/s00262-025-04178-x.

    PubMed 41051649

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CV09050101 mRNA vaccine (CVGBM) 12 μg, CV09050101 mRNA vaccine (CVGBM) 25 μg and CV09050101 mRNA vaccine (CVGBM) 50 μg in people with Glioblastoma, run by CureVac at 13 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Germany, Belgium, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (TRAEs) (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05938387, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.

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