ClinicalTrials.gg
Not yet recruitingNCT07930338Updated Nov 12, 2026

First Study Evaluating the Safety and Dosage of YG-01 in Patients With Glioblastoma

A Phase 1 interventional study of YG-01 Dose Level 1 and YG-01 Dose Level 2 in Glioblastoma, sponsored by YGION Biomedical GmbH. Not yet recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by YGION Biomedical GmbH · Phase 1, Interventional, and Treatment

Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
15
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 37 studies in Glioblastoma with a site in Austria — 7 open to participants now, 11 under way, 4 of them phase 3. Glioblastoma · Austria.

Planned enrollment
33rd of 35
15 · median 120
Started
2026
with 1 other
Phase 1
4 of 37
1 open now
Primary completion
2028-04
later than 7 of 10 live
Registered
37th of 37
by date

Among the 37 studies in Glioblastoma with a site in Austria, this one is the 33rd largest by planned enrollment of the 35 interventional ones that give a count, is one of 2 that started in 2026, is one of 4 in phase 1, reaches primary completion later than 7 of the 10 other live ones, and was the 37th registered.

Glioblastoma

2,134 studies on the registry are indexed under Glioblastoma; 466 are open to participants now.

Browse Glioblastoma studies →

Open to participants now

7 of the 37 studies in Glioblastoma with a site in Austria are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in Austria have not opened yet or have stopped. Only those recruiting at a site in Austria →

Who these studies take

Of the 339 Glioblastoma studies recruiting now, 234 (69%) set no upper age limit and 65 (19%) stop at 75 or younger; 27 take children under 18; 13 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study summary

This is a first-in-human, open-label, single-arm, dose-escalation Phase 1 clinical study evaluating the safety, tolerability, feasibility, and immunogenicity of the YG-01, a personalized neoantigen peptide-based cancer immunotherapy, in patients with diagnosed glioblastoma following standard-of-care therapy. The study will assess the safety and tolerability of repeated administrations of YG-01 and explore immune responses and clinical outcomes following treatment. The study includes sequential dose-escalation cohorts to evaluate the safety and tolerability of increasing dose levels of YG-01 and to identify a recommended dose for further clinical development.

03

Conditions studied

  • Glioblastoma

Browse trials for

Keywords

  • Glioblastoma
  • Neoantigen
  • Immunotherapy
  • Neoepitope
  • Personalized cancer immunotherapy
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Pre-Production Screening inclusion criteria:

  1. Patient provided written for study participation prior to initiation of any study specific activities/procedures.
  2. confirmed glioblastoma, IDH wild type, WHO CNS Grade 4 - classification according to WHO classification of CNS tumors 2021; patients of dose escalation cohorts are required to have undergone extensive tumor resection documented by post-surgical magnetic resonance imaging (MRI) demonstrating either no contrast enhancement or no greater than 1 cm x 1 cm x 1 cm volume of residual enhancing tumor.
  3. Age ≥18 years
  4. 0-1
  5. At least 4 manufacturable neoepitopes identified in a preceding tumor sample analysis study and availability of a manufacturing slot confirmed by the sponsor.
  6. Stable disease or no according to local investigator assessment, following at least two MRI scans taken a minimum of 8 weeks apart, both conducted after the completion of standard 6 weeks radiotherapy with concurrent temozolomide.

Pre-Therapy Screening inclusion criteria:

  1. Having completed maintenance temozolomide therapy, received at least 4 cycles of temozolomide, and having an interval of at least 4 weeks between the last dose of temozolomide and the first administration of study medication.
  2. Stable disease or no measurable disease according to local investigator assessment, following an MRI scan taken after the completion of maintenance temozolomide therapy.
  3. > 3 months at start of study treatment as clinically determined by the investigator.
  4. ECOG 0-1
  5. Availability of study medication confirmed by the sponsor.
  6. Absolute lymphocyte count (ALC) >0.75 x10\^9/L
  7. No need for dexamethasone or any other treatment within 1 week prior to baseline.
  8. No need for bevacizumab treatment within 1 week prior to baseline.

Pre-Production Screening exclusion criteria:

  1. Known or active or C infection, or active infections requiring oral or intravenous antibiotics or known infections that can cause a severe disease and pose a severe danger to lab personnel working on patient's blood or tissue.
  2. Concurrent participation in another interventional clinical trial studying a drug or treatment regimen.
  3. diseases (with the exception of autoimmune thyroid disease) that, in the investigator's judgement, may interfere with study participation.
  4. , not related to treatment for glioblastoma.
  5. History of severe reactions.
  6. Any condition that in the judgment of the investigator interferes with the probability that an individual patient may receive and benefit from YG-01 treatment (e.g., high risk of early disease progression / recurrence; immunocompromised status; anticipated compliance issues).
  7. Clinically relevant illness or condition which may affect the patient's safety during the study or impede the patient's ability to complete the study, as assessed by the investigator
  8. History of other (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) unless the patient has been disease-free for the last 5 years.
  9. Pregnancy or breastfeeding

Pre-Therapy Screening exclusion criteria:

  1. Abnormal (≥ grade 2 v6.0) laboratory values for hematology, liver and renal function (serum creatinine).
  2. HIV infection or active Hepatitis B or C infection, or active infections requiring oral or intravenous antibiotics or known infections that can cause a severe disease and pose a severe danger to lab personnel working on patient's blood or tissue.
  3. Concurrent participation in another interventional clinical trial studying a drug or treatment regimen.
  4. Clinically relevant autoimmune diseases (with the exception of autoimmune thyroid disease) that, in the investigator's judgement, may interfere with study participation.
  5. Any vaccination within 2 weeks prior to baseline.
  6. Immunosuppression, not related to prior treatment for glioblastoma.
  7. History of severe hypersensitivity reactions.
  8. Any condition that in the judgment of the investigator interferes with the probability that an individual patient may receive and benefit from YG-01 treatment (e.g., high risk of early disease progression / recurrence; immunocompromised status; anticipated compliance issues).
  9. Clinically relevant illness or condition which may affect the patient's safety during the study or impede the patient's ability to complete the study, as assessed by the investigator
  10. History of other malignancies (except for adequately treated basal or squamous cell carcinoma or carcinoma in situ) unless the patient has been disease-free for the last 5 years.
  11. Pregnancy or breastfeeding.
Terms in these criteria, in plain language(14)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

CTCAE grade

The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.

1
Mild.
2
Moderate.
3
Severe.
4
Life-threatening.
5
Death due to the event.

“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Dose Level 1

    Patients receive YG-01, a personalized neoantigen immunotherapy comprising patient-specific neoepitope peptides administered subcutaneously at Dose Level 1.

    Biological: YG-01 Dose Level 1

  • Experimental
    Dose Level 2

    Patients receive YG-01 at Dose Level 2 subcutaneously on the same schedule as Dose Level 1, started after Safety Committee review of Dose Level 1.

    Biological: YG-01 Dose Level 2

Interventions

  • BiologicalYG-01 Dose Level 1

    YG-01 administered subcutaneously at Dose Level 1 according to the study treatment schedule.

  • BiologicalYG-01 Dose Level 2

    YG-01 administered subcutaneously at Dose Level 2 according to the study treatment schedule.

06

What researchers measure

Primary outcomes

  1. Incidence of local and systemic adverse events within 7 days following each administration of YG-01

    Treatment-emergent local (injection-site) and systemic adverse events, graded by NCI CTCAE v6.0, starting within 7 days after each administration. Summarized per administration and overall, by severity, seriousness and relationship to YG-01.

    Time frame: From baseline until 7 days after each YG-01 administration.

Secondary outcomes

  1. Incidence of treatment-emergent adverse events over the study period

    All treatment-emergent adverse events during the treatment period, and YG-01-related adverse events during follow-up graded by NCI CTCAE v6.0.

    Time frame: From baseline until study completion

  2. Progression-free survival (PFS)

    Time from study treatment start (baseline) to tumor progression on MRI or death from any cause.

    Time frame: From baseline until progression or death (up to 24 months)

  3. Overall Survival (OS)

    Time from study treatment start (baseline) to death from any cause.

    Time frame: From baseline until death (up to 24 months)

Other outcomes

  1. Induction neoantigen-specific T-cell Responses

    T-cell responses against the patient-specific neoepitopes in peripheral blood, analyzed descriptively.

    Time frame: From Pre-Production Screening until end of study (up to 24 months)

  2. Induction of YG-01-specific antibody responses

    Antibody responses against YG-01 in serum, analyzed descriptively.

    Time frame: From Pre-Production Screening until end of study (up to 24 months)

  3. Induction of cytokine responses

    Changes in serum cytokine profiles will be assessed and analyzed descriptively.

    Time frame: From Pre-Production Screening until end of study (up to 24 months)

  4. Cytotoxicity potential of T cells

    The cytotoxic activity of neoantigen-specific T cells will be assessed in vitro and analyzed descriptively.

    Time frame: From Pre-Production Screening until end of study (up to 24 months)

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared. Summary results will be posted in CTIS and on ClinicalTrials.gov.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Apr 2028, 17 months later.

Of 82 industry-sponsored phase 1 interventional studies under Glioblastoma, half reached primary completion within 42 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 64. This study's planned 17 months is below that.

Counting every sponsor, half of 322 studies reached it within 44 months; a quarter within 29 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 28, 2026
First posted
Nov 12, 2026
StartEst.
Nov 2026
Primary completionEst.
Apr 2028
CompletionEst.
Nov 2029
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07930338
Lead sponsor
YGION Biomedical GmbH
Responsible party
Sponsor
First posted
Nov 12, 2026
Start date
Nov 2026 (estimated)
Primary completion
Apr 2028 (estimated)
Completion
Nov 2029 (estimated)
Last update
Nov 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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