NCT07365280Not yet recruitingPhase 2

Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma

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

Source: ClinicalTrials.gov · Last updated 26 Jan 2026

Brief summary (registry, in English)

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.

Status (registry): Not yet recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 78 (estimated)
First submitted: 5 Jan 2026
Start date: Jan 2026
Primary completion date: Dec 2028
Lead sponsor: ZSky Biotech Inc
Diseases: Glioblastoma
NCT number: NCT07365280

What you commit to

Study type: Interventional · Phase 2
Planned participants: 78
From Jan 2026 to the primary completion date, Dec 2028
No sites listed in no country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

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
Use of systemic immunosuppressive therapy within 30 days before randomization

Other illness

Known hypersensitivity to temozolomide or dacarbazine
Active autoimmune disease or requirement for systemic immunosuppressive therapy
Active infection including HIV, active hepatitis B or C, or syphilis
Uncontrolled cardiovascular, metabolic, or systemic disease
Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results

Other

Subjects meeting any of the following criteria are ineligible:
Pregnancy or breastfeeding

Who the study is looking for

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
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

Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.