NCT07715097尚未招募2 期
A Phase II Clinical Trial of Survivin-Targeted Dendritic Cell (DC) Injection for the Treatment of Newly DiagnosedGlioblastoma
Beijing Tricision Biotherapeutics Inc0 个研究点目标入组 30 人开始时间: 2026年9月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Primary Outcome Measure:Overall Survival (OS)
研究概览
简要总结
The overall objective of this study is to preliminarily evaluate the efficacy and safety of Survivin-targeted DC Cell Injection in the postoperative treatment of newly diagnosed glioblastoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 (inclusive) and 70 (inclusive) years old, with no gender restriction.
- •Pathologically confirmed newly diagnosed WHO grade 4 glioblastoma multiforme (GBM).
- •Positive for Survivin expression by immunohistochemistry.
- •Extent of tumor resection meets grade 1 or 2 of the RANO surgical resection classification (definition ofRANO classification is provided in Appendix 1).
- •Karnofsky Performance Status (KPS) score ≥ 70 prior to enrollment.
- •Agree not to receive any other glioblastoma-directed therapies during the trial, except for radiotherapy,temozolomide, and targeted Survivin DC cell injection.
- •Female subjects must have a negative pregnancy test; both male and female subjects agree to use non-pharmacological contraceptive measures during the trial period.
- •Adequate basic hematological function: a) White blood cell count ≥ 2.0 × 10⁹/L b) Absolute neutrophilcount ≥ 1.5 × 10⁹/L c) Lymphocyte count ≥ 0.5 × 10⁹/L d) Platelet count ≥ 100 × 10⁹/L e) Hemoglobin ≥ 9.0g/dL (90 g/L).
- •Expected survival ≥ 14 weeks.Expected survival ≥ 14 weeks.
- •Sufficient venous access for mononuclear cell apheresis and no other contraindications toleukapheresis.
- •Voluntary participation in the clinical study; subject or legal guardian fully understands the study,provides informed consent, and is willing to comply with and complete all study procedures.
排除标准
- •History of other malignancies or concurrent other malignancies (except adequately treated carcinoma insitu of the cervix, basal cell or squamous cell skin cancer, locally confined prostate cancer after radicalresection, thyroid cancer, and ductal carcinoma in situ after radical resection).
- •Contrast-enhanced MRI within 7 days after tumor surgery shows a residual lesion diameter > 1 cmcompared with preoperative status.
- •Use of 5-aminolevulinic acid dye during surgery.
- •Failure to complete at least two-thirds of the prescribed total dose of conformal radiotherapy over theroutine 6-week period, or failure to complete a total of 5 weeks of concurrent temozolomide chemotherapyas scheduled.
- •Interval between the start of 6-week concurrent chemoradiotherapy and the completion of surgeryexceeds 50 days.
- •Disease progression documented after concurrent chemoradiotherapy and prior to study treatmentinitiation.
- •Hypersensitivity to any active ingredient or excipient of the investigational product (including sodiumchloride injection containing 10% human albumin), or history of allergy to penicillin or ampicillin.
- •Pregnant or lactating female subjects.
- •Administration of corticosteroids within 7 days prior to apheresis of peripheral blood mononuclear cells.
- •Expected daily dose of corticosteroids (e.g., dexamethasone) exceeding 2 mg/day, or single doseexceeding 10 mg, within 30 days before the first dose and during the treatment period.
- •Requirement for immunosuppressive agents during the study period.
- •Receipt of immune cell therapy within 6 months prior to screening.
- •Use of any anti-T cell therapy within 4 weeks prior to screening.
- •Acute infection or unexplained fever: active viral, bacterial, or fungal infection requiring specific therapy(e.g., antibiotics); unexplained fever with body temperature > 38°C.
- •Positive HIV antibody, positive syphilis antibody, positive HBsAg, positive HBcAb, positive or elevatedperipheral blood HBV DNA titer above upper limit of normal (ULN), positive anti-HCV antibody or positiveHCV RNA.
- •Presence of severe or unstable cardiac, pulmonary, hepatic, renal, or coagulation disorders, including:a)Symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia;b) Acute myocardialinfarction within 6 months;c) Exacerbation of chronic obstructive pulmonary disease or other respiratorydisorders requiring hospitalization;d) SGOT (AST) > 3 × ULN, SGPT (ALT) > 3 × ULN, total bilirubin > 1.5 ×ULN;e) Serum creatinine > 1.5 × ULN;f) Coagulation parameters: international normalized ratio (INR) > 1.5 ×ULN; activated partial thromboplastin time (APTT) > 1.5 × ULN;g) Severe psychiatric disorder, poorcompliance, or lack of legal capacity to consent;h) Severe neurological disease or neurological deficit,diffuse leptomeningeal disease, or concurrent neurodegenerative disease;i) Immunodeficiency orautoimmune disease, including systemic lupus erythematosus, polymyositis, insulin-dependent diabetesmellitus, etc.
- •History of organ transplantation.
- •Inability or unwillingness to undergo magnetic resonance imaging (MRI) scans during the study.
- •Any other circumstances in which the investigator deems the subject unsuitable for enrollment in thisclinical trial (including but not limited to poor compliance, drug abuse, etc.).
结局指标
主要结局
Primary Outcome Measure:Overall Survival (OS)
时间窗: From the date of glioblastoma (GBM) surgery until death from any cause, assessed up to 36 months.
次要结局
- Progression-Free Survival (PFS)(From date of glioblastoma (GBM) surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.)
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