GlioblastomaPhase 2NCT07365280
Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma
A Phase 2 study testing Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 and Temozolomide (TMZ) in people with Glioblastoma, run by ZSky Biotech Inc.
Trial summary
This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 and Temozolomide (TMZ)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 9 Jan 2026to 24 Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Participants must meet all the following criteria to be eligible:
- Age 18 to 75 years, inclusive
- Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
- Molecular diagnosis of IDH1/IDH2 wild-type
- Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy
- Karnofsky Performance Status (KPS) score of 50 to 100
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- Adequate hematologic, hepatic, renal, and coagulation function
- Availability of sufficient tumor tissue and blood samples for neoantigen identification
- Adequate venous access for PBMC collection
- Life expectancy greater than 3 months
- Willingness to use effective contraception during study treatment and for 3 months thereafter
- Ability to understand and willingness to sign written informed consent
Who cannot join
- Subjects meeting any of the following criteria are ineligible:
- Not suitable for standard temozolomide-based chemoradiotherapy
- Prior participation in another interventional clinical trial within 4 weeks before randomization
- Prior implantation of carmustine wafers within 6 months
- Known hypersensitivity to temozolomide or dacarbazine
- Active autoimmune disease or requirement for systemic immunosuppressive therapy
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- Active infection including HIV, active hepatitis B or C, or syphilis
- Use of systemic immunosuppressive therapy within 30 days before randomization
- Uncontrolled cardiovascular, metabolic, or systemic disease
- Pregnancy or breastfeeding
- Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-Label, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 in Combination With Temozolomide as Adjuvant Therapy in Patients With Newly Diagnosed Glioblastoma After Surgery and Concurrent Chemoradiotherapy
This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM).
Eligible patients with histologically confirmed, IDH1/IDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone.
The primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.
- Conditions
- Glioblastoma
- Being tested
- Personalized Dendritic Cell Vaccine ZSNeo-DC1.1, Temozolomide (TMZ)
- Keywords
- DC, Personalized neoantigen-pulsed autologous dendritic cells vaccine
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized Dendritic Cell Vaccine ZSNeo-DC1.1Biological
Also called Temozolomide
Patients receive six subcutaneous injections of ZSNeo-DC1.1 during adjuvant temozolomide chemotherapy. ZSNeo-DC1.1 is administered at a fixed dose of 1 × 10⁷ cells per injection according to the assigned immunization schedule. Temozolomide is administered as per protocol.
Temozolomide (TMZ)Drug
Patients receive standard adjuvant temozolomide chemotherapy alone
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide. Receives: Biological: Personalized Dendritic Cell Vaccine ZSNeo-DC1.1; Drug: Temozolomide (TMZ) |
| Control | Active comparator | Standard adjuvant temozolomide chemotherapy alone Receives: Drug: Temozolomide (TMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria
Measured: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months
Secondary outcomes (7)
OS
From randomization until death from any cause
Measured: From randomization until death from any cause，assessed up to 36 months
Overall Survival Rates
Measured: 12 months, 18 months, and 24 months
Investigator-Assessed Progression-Free Survival
Measured: From randomization until disease progression or death，assessed up to 24 months
Disease Control Rate (DCR)
Measured: During treatment period
Best Overall Response (BOR)
Measured: During treatment period
6. Clinical Benefit Rate (CBR)
Measured: During treatment period
Safety and Tolerability
Incidence and severity of adverse events and serious adverse events graded according to NCI CTCAE v5.0
Measured: From first dose until 30 days after last dose，assessed up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start9 Jan 2026 (estimated)
- Primary completion24 Dec 2028 (estimated)
- Study completion24 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ZSky Biotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365280
- Sponsor's protocol ID
- ZSKY2025-1005
- Status last verified
- Dec 2025
- First submitted
- 5 Jan 2026
- Last updated
- 26 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 in Combination With Temozolomide as Adjuvant Therapy in Patients With Newly Diagnosed Glioblastoma After Surgery and Concurrent Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT07365280
- Acronym / sponsor ID
- ZSKY2025-1005
- Conditions
- Glioblastoma
- Keywords
- DC, Personalized neoantigen-pulsed autologous dendritic cells vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- ZSky Biotech IncIndustry (pharma, biotech, devices)
- Study start
- 9 Jan 2026 (estimated)
- Primary completion
- 24 Dec 2028 (estimated)
- Study completion
- 24 Dec 2028 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM).
Eligible patients with histologically confirmed, IDH1/IDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone.
The primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: Personalized Dendritic Cell Vaccine ZSNeo-DC1.1, Drug: Temozolomide (TMZ)Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide. |
| Control | Active comparator | Drug: Temozolomide (TMZ)Standard adjuvant temozolomide chemotherapy alone |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Age 18 to 75 years, inclusive
- Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
- Molecular diagnosis of IDH1/IDH2 wild-type
- Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy
- Karnofsky Performance Status (KPS) score of 50 to 100
Key exclusion criteria (11 listed)
- Not suitable for standard temozolomide-based chemoradiotherapy
- Prior participation in another interventional clinical trial within 4 weeks before randomization
- Prior implantation of carmustine wafers within 6 months
- Known hypersensitivity to temozolomide or dacarbazine
- Active autoimmune disease or requirement for systemic immunosuppressive therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personalized Dendritic Cell Vaccine ZSNeo-DC1.1Also: TemozolomidePatients receive six subcutaneous injections of ZSNeo-DC1.1 during adjuvant temozolomide chemotherapy. ZSNeo-DC1.1 is administered at a fixed dose of 1 × 10⁷ cells per injection according to the assigned immunization schedule. Temozolomide is administered as per protocol. | Biological | Experimental |
| Temozolomide (TMZ)Patients receive standard adjuvant temozolomide chemotherapy alone | Drug | Control, Experimental |
Primary outcome
PFS
Time frame: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months
Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria
7 secondary outcomes
OS
Time frame: From randomization until death from any cause，assessed up to 36 months
Overall Survival Rates
Time frame: 12 months, 18 months, and 24 months
Investigator-Assessed Progression-Free Survival
Time frame: From randomization until disease progression or death，assessed up to 24 months
Disease Control Rate (DCR)
Time frame: During treatment period
Best Overall Response (BOR)
Time frame: During treatment period
6. Clinical Benefit Rate (CBR)
Time frame: During treatment period
Safety and Tolerability
Time frame: From first dose until 30 days after last dose，assessed up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 and Temozolomide (TMZ) in people with Glioblastoma, run by ZSky Biotech Inc.
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 12 inclusion and 11 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: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Ma, M.M (+0518-82342973, xiaomin.ma@zskybio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jan 2026.