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AzTrials

Glioblastoma Multiforme of BrainPhase 1NCT04968366

Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

A Phase 1 study testing Autologous dendritic cells pulsed with multiple neoantigen peptides. and Temozolomide adjuvant chemotherapy in people with Glioblastoma Multiforme of Brain, run by Beijing Tiantan Hospital at 1 site in China.

Completed

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

Official record
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Trial summary

This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccine to treat adult postoperative patients with newly-diagnosed glioblastoma, in combination with… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Glioblastoma Multiforme of Brain
What is being tested?
Autologous dendritic cells pulsed with multiple neoantigen peptides. and Temozolomide adjuvant chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteChina
Study dates
30 Jul 2021to 31 Oct 2025
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age from 18 to 75 years (including 18 and 75 years old);
  • Newly-diagnosed glioblastoma confirmed by histopathological exams;
  • IDH1- and IDH2-wild-type gliomas;
  • Extent of resection of enhancing lesions > 90%;
  • Karnofsky Performance Score(KPS) ≥ 60%;
  • Adequate organ functions:
  • The absolute value of white blood cells ≥ 2.5×10 9/L; Hemoglobin levels> 100 g/L; Platelet counts > 100×109/L; Levels of Alanine aminotransferase, aspartate aminotransferase <2.5 x ULN; Serum creatinine levels <1.5 x ULN.

Who cannot join

  • Subjects with any other active malignancy;
  • Subjects received the placement of Carmustine implants within 6 months before the inclusion;
  • Subjects with active HBC, HCV or HIV infection;
  • Subjects with grade 2 -3 hypertension or uncontrolled hypertension;
  • Subjects with severe cardio- or cerebro- vascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, etc.;
  • Subjects with uncontrolled autoimmune diseases such as hemolytic anemia, psoriasis and rheumatoid arthritis, etc.;
Show all 17Show fewer
  • Subjects with severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;
  • Subjects receiving immunosuppressants after organ transplantation;
  • Within four weeks before the DC vaccinations, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid);
  • Subjects with unstable pulmonary embolism, deep venous embolism, or other major arterial and venous thromboembolic events that occur within 30 days before the enrollment; receiving ongoing anticoagulant therapy;
  • Subjects in pregnancy or breastfeeding, or those who plan to become pregnant during treatment or within 2 months after the end of treatment;
  • Within the 14 days before enrollment, subjects with active infections or uncontrolled infections that require systemic antibiotic treatment (except for simple urinary tract infections or upper respiratory tract infections);
  • Subjects who have received other vaccine therapies or gene-modified cell therapy before enrollment;
  • Subjects with number of the predicted neoantigen peptides less than 5;
  • Subjects with other conditions that would interfere trial participation at the investigator's discretion;
  • Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures; or patients who are unwilling or unable to comply with the research procedures;
  • Subjects who participated or are participating in other clinical trials within 4 weeks before enrollment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Tiantan Hospital

    Beijing, Beijing Municipality, 100730

Other trials in China

About this study

Official title: Phase I Clinical Study of Safety & Efficacy of DC Vaccine and TMZ for the Treatment of Newly-diagnosed Glioblastoma After Surgery

This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccine to treat adult postoperative patients with newly-diagnosed glioblastoma, in combination with the standard-of-care Temozolomide (TMZ) chemotherapy.

Read the detailed description

This is a single-center, single-arm phase I study to determine the safety and preliminary efficacy of autologous dendritic cells (DCs) loaded with multiple tumor neoantigen peptides administered as a cancer-treatment vaccination for the treatment of newly-diagnosed glioblastoma (GBM). The subjects are adult GBM patients who have undergone surgical resection. After the completion of TMZ concurrent chemoradiation, and, during conventional adjuvant TMZ chemotherapy, subjects will receive autologous DC vaccine treatments as scheduled. Ten subjects will be enrolled. The autologous genetic-modification-free DC cells will be loaded with multiple tumor neoantigen peptides and administered (i.d) to subjects. After 5 injections, the investigator will review subject's tolerance and compliance, and decide whether or not to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of TMZ adjuvant chemotherapy to assess patient's immune response. According to the result, investigators will be decided whether to perform more 1-2 treatment cycles (5-8 infections/cycle) to strengthen the effectiveness.

Being tested
Autologous dendritic cells pulsed with multiple neoantigen peptides., Temozolomide adjuvant chemotherapy

What participants receive

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

  • Autologous dendritic cells pulsed with multiple neoantigen peptides.Biological

    Each dosage of Dendritic Cells (DC) vaccine contains 2-10 million DC cells, loaded with 5-20 tumor neoantigen peptides. DC vaccine will be administered (i.d) around lymph nodes of the groin and Axillary at 2nd, 3rd, 4th, 7th and 11th week after the completion of concurrent Temozolomide chemoradiation. After 5 injections, the investigator will review subject's tolerance and compliance; and, decide whether to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of Temozolomide adjuvant chemotherapy to assess the patient's immune response. According to the result, investigators will decide whether to perform 1-2 more treatment cycles (5-8 injections/cycle) to strengthen the effectiveness

  • Temozolomide adjuvant chemotherapyDrug

    Also called the standard-of-care adjuvant chemotherapy for GBM patients

    Temozolomide is administered as the standard-of-care adjuvant chemotherapy, in combination with the DC vaccines to treat the enrolled patients.

Study groups in NCT04968366
Study groupRoleWhat they receive
DC vaccine groupExperimentalSubjects will receive five to eight doses of the DC vaccine through i.d. injection into regions near to the groin and axillary during they receive TMZ adjuvant chemotherapy
Receives: Biological: Autologous dendritic cells pulsed with multiple neoantigen peptides.; Drug: Temozolomide adjuvant chemotherapy

What is being measured

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

  1. Incidence of Treatment-Emergent Adverse Events (AEs)

    AEs were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

    Measured: All the AEs were recorded from the first shot to 8 weeks after the last shot.

Secondary outcomes (4)

  1. Proportions of patients with positive peripheral tumor specific immune response after the DC vaccinations

    The peripheral tumor specific immune response is measured by the IFN-γ release ELISPOT assay, using the peripheral blood mononuclear cells (PBMCs) that are collected before the vaccine injection (baseline), one week after the 3r, 5th and the last injection, respectively. The positive response is defined as "≥ 55 spot-forming cells in each million PBMCs" or "number of spot-forming cells increase by 3-fold after the DC vaccination compared with the baseline".

    Measured: start from the inclusion timepoint to one week after the last injection.

  2. Progression-free survival

    months from the date of surgery to tumor recurrence or progression

    Measured: From date of surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months

  3. Overall survival

    months from the date of surgery to death

    Measured: From date of surgery until the date of death from any cause, assessed up to 60 months

  4. Rate of the patients who survive for more than one year after surgery in all the included patients who receive the DC vaccine

    One-year survival rate

    Measured: From date of surgery until one year after surgery

Timeline

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

  1. First posted20 Jul 2021
  2. Study start30 Jul 2021
  3. Primary completion30 Apr 2024
  4. Study completion31 Oct 2025

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968366
Sponsor's protocol ID
KY 2021-021-02
Status last verified
Apr 2026
First submitted
6 Jul 2021
Last updated
4 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang Y, Chi X, Liu K, Ma Y, Zhang S, Ma X, Sun S, Zhang Y, Zhang K, Huang N, Cheng X, Ji N. Personalized neoantigen-pulsed autologous dendritic cells in newly-diagnosed glioblastoma: a phase Ib trial. Nat Commun. 2026 Jul 4. doi: 10.1038/s41467-026-75066-w. Online ahead of print.

    PubMed 42401550

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Autologous dendritic cells pulsed with multiple neoantigen peptides. and Temozolomide adjuvant chemotherapy in people with Glioblastoma Multiforme of Brain, run by Beijing Tiantan Hospital at 1 site in China.

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 7 inclusion and 17 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. 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-Emergent Adverse Events (AEs) (time frame: All the AEs were recorded from the first shot to 8 weeks after the last shot.). 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 NCT04968366, 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 4 May 2026.

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