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

ConditionGlioblastoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZSky Biotech Inc

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized Dendritic Cell Vaccine ZSNeo-DC1.1

    Biological/Vaccine

    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

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: ExperimentalExperimental treatment 2 interventions
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

PFS

Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria

Time frame
From randomization until disease progression or death, whichever occurs first，assessed up to 24 months

Secondary outcomes

1

OS

From randomization until death from any cause

Time frame
From randomization until death from any cause，assessed up to 36 months
2

Overall Survival Rates

Time frame
12 months, 18 months, and 24 months
3

Investigator-Assessed Progression-Free Survival

Time frame
From randomization until disease progression or death，assessed up to 24 months
4

Disease Control Rate (DCR)

Time frame
During treatment period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ZSky Biotech Inc

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: