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

Официальное название

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

Обзор

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.

Вмешательства

• Биопрепарат Personalized 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.
• Препарат Temozolomide (TMZ)
  Patients receive standard adjuvant temozolomide chemotherapy alone

Первичные конечные точки

• PFS [Срок оценки: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months]

Вторичные конечные точки (7)

• OS [Срок оценки: From randomization until death from any cause，assessed up to 36 months]
• Overall Survival Rates [Срок оценки: 12 months, 18 months, and 24 months]
• Investigator-Assessed Progression-Free Survival [Срок оценки: From randomization until disease progression or death，assessed up to 24 months]
• Disease Control Rate (DCR) [Срок оценки: During treatment period]
• Best Overall Response (BOR) [Срок оценки: During treatment period]
• 6. Clinical Benefit Rate (CBR) [Срок оценки: During treatment period]
• Safety and Tolerability [Срок оценки: From first dose until 30 days after last dose，assessed up to 24 months]

Критерии участия

Критерии включения

Participants must meet all the following criteria to be eligible:

Критерии включения

• 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

Критерии исключения

Критерии исключения

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
• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07365280 · ZSKY2025-1005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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