Clinical Study of an Dendritic and Glioma Cells Fusion Vaccine With IL-12 for Treatment-naïve GBM Patients.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Progression free survival (PFS) at 6 months
研究概览
简要总结
A multi-center, open-label, single-arm, phase I/II clinical study is designed to test the safety and immunogenicity of an investigational Dendritic and Glioma Cells Fusion vaccine given with IL-12 for treatment-naïve patients after resection of glioblastoma.
详细描述
This clinical trail includes two phases: basic treatment phase and immunotherapy phase. In basic treatment phase, patients will receive concomitant radiation and TMZ-chemotherapy. In immunotherapy phase, besides maintenance chemotherapy with TMZ, Fusion cells will be administered with IL-12 to enhance the immunity of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years; Male or Female.
- •Treatment-naïve patients after Resection of Glioblastoma.
- •Histologically confirmed Glioblastoma.
- •White blood cell count (WBC) ≥ 3.0 x 109/L; peripheral blood lymphocyte (PBL) ≥ 25%.
- •Echocardiographic assessment of left ventricular ejection fraction (LVEF) ≥ 40% within 1 month of enrollment.
- •Patients must be able to understand the investigational nature of the study and provide informed consent.
排除标准
- •Those who are allergic constitution, or allergic to biological products, or have contraindications to CT and MRI1 contrast agents.
- •Those with severe autoimmune diseases or immunodeficiency diseases.
- •Those who are expected to take systemic corticosteroids within three months.
- •Those who needs long-term usage of immunosuppressive agents.
- •Those with infectious diseases, including syphilis, AIDS, hepatitis B, hepatitis C, etc.
- •Those who plan to receive any other anti-tumor treatment during the trial.
- •Combined with serious primary diseases of cardiovascular, liver and kidney, and liver function (ALT, AST, Y-GT) exceeding 1.5 times of the upper limit: BUN or Cr exceeding 1.5 times of the upper limit of normal value.
- •Patients with other malignant tumors.
- •Those with active infections, etc.
- •Suspected or confirmed a history of alcohol and drug abuse.
- •Psychiatric illness, intellectual and language disabilities that compromise the informed consent process, at the discretion of the investigator.
- •Women who are pregnant or nursing.
- •Women of childbearing age who refuse to contraception.
- •Active participation in another clinical treatment trials.
- •According to the judgment of the investigator, other conditions that the plan cannot be followed.
研究组 & 干预措施
Safety Evaluation Group
Basic treatment phase:
The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days).
Immunotherapy phase:
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour.
干预措施: Dendritic Cell/Tumor Fusion Vaccine (Biological)
Safety Evaluation Group
Basic treatment phase:
The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days).
Immunotherapy phase:
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour.
干预措施: Temozolomide (Drug)
Safety Evaluation Group
Basic treatment phase:
The patients have surgery followed by concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days).
Immunotherapy phase:
Maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle. Fusion cells will be suspended in 0.5 mL normal saline and then injected intradermally close to a cervical lymph node. IL-12 will be injected subcutaneously at the same side at dose of 6ug twice for interval of one hour.
干预措施: Interleukin-12 (Drug)
结局指标
主要结局
Progression free survival (PFS) at 6 months
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months
Assessed from this study start date to the date of the first observation of clinical or radiographic disease progression or death due to any cause. Patients will be censored at the time they are last known to be alive and progression free (if withdrawn or lost to follow-up).
Adverse Events (AE) / Serious Adverse Events (SAE)
时间窗: 2-3 years
AE/SAE associated with the intervention will be captured throughout the treatment portion of the study. All adverse events will be then compiled and these patients will be recorded.
次要结局
- Immunological Assays(2-3 years)
- Overall survival (OS) time(From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 120 months)