Glioblastoma
Conditions
Keywords
DC, Personalized neoantigen-pulsed autologous dendritic cells vaccine
Brief 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). 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.
Interventions
BIOLOGICALPersonalized Dendritic Cell Vaccine ZSNeo-DC1.1
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.
DRUGTemozolomide (TMZ)
Patients receive standard adjuvant temozolomide chemotherapy alone
Sponsors
ZSky Biotech Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria to be eligible: Inclusion Criteria 1. Age 18 to 75 years, inclusive 2. Histologically confirmed newly diagnosed glioblastoma (WHO grade IV) 3. Molecular diagnosis of IDH1/IDH2 wild-type 4. Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy 5. Karnofsky Performance Status (KPS) score of 50 to 100 6. Adequate hematologic, hepatic, renal, and coagulation function 7. Availability of sufficient tumor tissue and blood samples for neoantigen identification 8. Adequate venous access for PBMC collection 9. Life expectancy greater than 3 months 10. Willingness to use effective contraception during study treatment and for 3 months thereafter 11. Ability to understand and willingness to sign written informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | From randomization until death from any cause，assessed up to 36 months | From randomization until death from any cause |
| Overall Survival Rates | 12 months, 18 months, and 24 months | — |
| Investigator-Assessed Progression-Free Survival | From randomization until disease progression or death，assessed up to 24 months | — |
| Disease Control Rate (DCR) | During treatment period | — |
| Best Overall Response (BOR) | During treatment period | — |
| 6. Clinical Benefit Rate (CBR) | During treatment period | — |
| Safety and Tolerability | From first dose until 30 days after last dose，assessed up to 24 months | Incidence and severity of adverse events and serious adverse events graded according to NCI CTCAE v5.0 |
Contacts
CONTACTXiaomin Ma, M.M
Outcome results
None listed