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临床试验 NCT07501559 针对Recurrent Glioblastoma Multiforme(GBM)目前招募中。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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卡片视图
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM) I期, II期 40
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临床试验NCT07501559旨在研究治疗，主要针对Recurrent Glioblastoma Multiforme(GBM)。这是一项I期 II期 干预性研究试验，目前试验状态为招募中。试验始于2026年4月1日，计划招募40名患者。该研究由Jecho Biopharmaceuticals Co., Ltd.主导，预计于2030年4月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2026年3月30日。
简要概括
The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).
详细描述
This is a multicenter, open-label, Phase Ib clinical trial with an on-demand dosing design, evaluating the safety and efficacy of JL15003 Injection in patients with recurrent glioblastoma (rGBM). The trial consists of a Screening Period (Week -5 to Week -1), a Treatment Period (from Week 1 until protocol-defined treatment discontinuation criteria are met), and a Survival Follow-up Period (up to 15 years or until all ...显示更多
官方标题
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)
疾病
Recurrent Glioblastoma Multiforme(GBM)其他研究标识符
- Jecho-15003-002
主要目的
治疗方法
分配方式
不适用
干预模型
单组试验
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性administration of JL15003 Injection | JL15003Injection Intratumoral or intracavitary administration of JL15003 Injection as needed |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Any changes in the incidence and severity of Adverse Events (AEs) | From the signing of the informed consent by the first subject to the end of the study，up to 15 years |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Overall survival (OS) | Up to 15 years | |
12-month OS rate | From the first administration to 12 months after the first administration | |
Objective response rate (ORR) | Up to 12 months | |
Disease control rate (DCR) | Up to 12 months | |
Progression-free survival (PFS) | Up to 15 years | |
Duration of response (DOR) | Up to 15 years | |
Viral shedding:Copy number of JL15003 in blood | Assays are performed in the central laboratory | UP to 3 years |
Copy number of JL15003 in throat swab samples | Assays are performed in the central laboratory | Up to 3 years |
Copy number of JL15003 in fecal samples | Assays are performed in the central laboratory | Up to 3 years |
Copy number of JL15003 in cerebrospinal fluid (CSF) samples | Assays are performed in the central laboratory | Up to 3 years |
Copy number of JL15003 in cystic fluid samples | Assays are performed in the central laboratory | Up to 3 years |
参与助手
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- 1. Age >= 18 years of age;
- 2. Histopathologic or radiological confirmed recurrent supratentorial GBM and measurable lesions ( <=3 cm on contrast-enhanced MRI prior to JL15003 administration);
- 3. Histopathology consistent with the 2021 World Health Organization (WHO) glioblastoma classification;
- 4. Refractory or relapsed following standard-of-care therapy or intolerance to standard therapy (surgical resection followed by radiotherapy and concurrent/adjuvant temozolomide);
- 5. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;
- 6. Karnofsky Performance Status (KPS) >=70 and expected survival time >= 3 months;
- 7. Patients should have received a boost immunization with trivalent inactivated poliovirus vaccine between 1 week to 6 months prior to administration of the study drug, with a neutralizing antibody titer >=1:8 prior to the administration;
- 8. Able to undergo brain MRI with and without contrast;
- 9. All subjects and their partners must have no plans for conception from screening until 90 days after the end of the observation period and must agree to use effective non-pharmacological contraceptive measures during the trial;
- 10. Subjects voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.
- 1. Subjects who are allergic to any component of the investigational drug, contrast agent Maganweixian, or albumin;
- 2. Patients with life-threatening cerebral hernia syndrome as determined by the investigator;
- 3. Patients with combined severe or active diseases are defined as follows:
- (1) Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax > 99.5 F/37.5 C) for more than a week;
- (2) Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or organ transplantation;
- (3) Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4);
- (4) History of vascular diseases (including myocardial infarction, unstable angina pectoris, cerebrovascular disease, peripheral arterial disease, or aortic disease, etc.) within 6 months;
- (5) Uncontrolled hypertension (defined as systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg on at least 2 separate occasions, despite antihypertensive medication);
- (6) Patients with active thrombosis, active bleeding, or pathological conditions posing a high risk of bleeding (e.g., coagulation disorders);
- (7) Patients with active autoimmune disease requiring systemic immunomodulatory therapy within 3 months;
- 4. Patients with known history of agammaglobulinemia;
- 5. Patients with tumor in the brainstem, cerebellum or spinal cord, or leptomeningeal disease; Subjects with diffuse subependymal disease;
- 6. Head MRI suggests tumor enhancement with marginal invasion of the ventricular wall or postoperative tumor cavity connecting to the ventricle; The tumor crosses the midline;
- 7. Patients with a history of neurological complications due to poliovirus infection;
- 8. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups);
- 9. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin;
- 10. Patients who have received antitumor therapy (including but not limited to chemotherapy, targeted therapy, immunotherapy, TTFields, or other investigational antitumor drugs) within 4 weeks prior to the first dose of the study drug or within 5 half-lives of the previous drug (whichever is longer), and has not recovered from the toxicities (i.e., to <= Grade 1 per CTCAE v5.0, except for alopecia; peripheral neuropathy up to Grade 2 is acceptable);
- 11. Patients who have received radiation therapy within 12 weeks prior to the administration of the investigational drug, excluding those who have undergone radiation therapy for progressive diseases outside the radiation area;
- 12. Patients on greater than 5 mg per day of dexamethasone or equivalent doses of other hormones (inhaled or localized use of hormones, in the absence of active autoimmune disease) within 2 weeks prior to the administration of the investigational drug;
- 13. The laboratory tests meet the following standards:
- (1) Hemoglobin <90g/L;
- (2) Platelet count <100×10^9/L;
- (3) Neutrophil count <1.5×10^9/L;
- (4) Creatinine > 1.5 × upper limit of normal (ULN);
- (5) Serum total bilirubin (TBIL) > 1.5×ULN;
- (6) AST/ALT> 2.5×ULN;
- (7) Prothrombin and Partial Thromboplastin Times >1.2×ULN;
- 14. Subjects with positive syphilis antibody, or active hepatitis \[For hepatitis B: positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV-DNA copy number above the upper limit of normal; for hepatitis C: positive HCV antibody and HCV RNA copy number above the upper limit of normal\];
- 15. Subjects who have received any vaccination within 4 weeks prior to the administration of the study drug, with the exception of the inactivated poliovirus vaccine, non-live seasonal influenza vaccines, or inactivated COVID-19 vaccines, mRNA vaccines;
- 16. Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment;
- 17. Subjects who are unsuitable for participation in this study at the Investigator's discretion.
Jecho Biopharmaceuticals Co., Ltd.研究中心联系人
联系人: Hongwei Liu, +86 188 1466 8239, [email protected]
1 位于 1 个国家/地区的研究中心
Huashan Hospital, Shanghai Medical College, Fudan University & Beijing TianTan Hospital,Capital Medical University, Shanghai, China
Jinsong Wu, MD, 联系人, +86 21 5288 7200, [email protected]
Jing Zhang, MD, 联系人
招募中