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Tests treatment safety and results for Recurrent Glioblastoma Multiforme(GBM)
Official title A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of JL15003 Injection in Patients With Recurrent Glioblastoma (rGBM)
ClinicalTrials.gov ID: NCT07501559
What this study is testing
What is JL15003Injection?
JL15003Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for recurrent glioblastoma multiforme(gbm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to evaluate the safety and efficacy of JL15003 Injection in subjects with recurrent glioblastoma (rGMB).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- 5\. Tolerable to intratumoral/intracavitary Ommaya reservoir catheter implantation;
You likely can't join if
- 1\. people 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...
- (2) Patients with known history of immunodeficiency (e.g., positive HIV antibody test), other acquired or congenital immunodeficiency diseases, or...
- (3) Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association (NYHA) Class 3 or 4);
See the full eligibility criteria
Who can join
- 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...
- 8\. Able to undergo brain MRI with and without contrast;
- 9\. All people 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...
- 10\. people voluntarily participate in the study, sign informed consent forms, have good compliance, and cooperate with follow-up.
What rules you out
- 1\. people 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; people 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...
- 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...
- 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...
- 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\. people 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...
- 15\. people 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...
- 16\. Pregnancy or lactation, and a woman of childbearing potential who has a positive pregnancy test (within 7 days) prior to treatment;
- 17\. people who are unsuitable for participation in this study at the Investigator's discretion.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.