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New treatment option for Glioma
Official title BC008-1A Injection for Recurrent CNS WHO G4 Glioma
ClinicalTrials.gov ID: NCT06773481
What this study is testing
What is BC008-1A?
BC008-1A is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for glioma.
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 purpose of this Phase I clinical study is to evaluate the safety, preliminary efficacy and pharmacokinetic characteristics of BC008-1A injection in subjects with recurrent CNS WHO grade 4 glioma. This is a randomized and open-label study, with two dose groups set up, and 10 to 20 subjects will be enrolled in each group.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
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
- Voluntarily sign the informed consent form;
- Recurrent CNS WHO grade 4 glioma: people with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as...
- Male or female aged ≥ 18 years old;
- Expected survival time ≥ 12 weeks;
- According to the RANO criteria, there is at least one measurable intracranial tumor lesion;
You likely can't join if
- Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;
- Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or...
- Having an autoimmune disease or a history of autoimmune diseases or related symptoms;
- people who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);
- people who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot...
- people with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;
See the full eligibility criteria
Who can join
- Voluntarily sign the informed consent form;
- Recurrent CNS WHO grade 4 glioma: people with CNS WHO grade 4 glioma confirmed by histopathology, who have experienced disease progression as diagnosed by MRI and evaluated by RANO criteria after standard treatment and...
- Male or female aged ≥ 18 years old;
- Expected survival time ≥ 12 weeks;
- According to the RANO criteria, there is at least one measurable intracranial tumor lesion;
- KPS ≥ 70;
- Have sufficient hematological function, liver function and renal function, and meet the following laboratory test results before enrollment (withoutusing any cell growth factors, platelet and red blood cell transfusion...
- Basically normal liver function: Total bilirubin (TBIL) ≤ 1.5 × ULN (patients with known Gilbert disease with serum bilirubin level ≤3 × ULN can be included), alanine aminotransferase (ALT) ≤ 2.5 × ULN, aspartate...
- Basically normal renal function: Creatinine (Cr) ≤ 1.5 × ULN, or estimated glomerular filtration rate (eGFR) ≥ 30 mL/min;
- Basically normal coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN, activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for people receiving anticoagulant...
- Basically normal hematological system: Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L (without granulocyte colony-stimulating factor treatment), platelet (PLT) ≥ 100 × 10\^9/L, hemoglobin (Hb) ≥ 90 g/L, white blood...
- Female people of childbearing age or male people whose partners are women of childbearing age need to agree to take effective contraceptive measures during the trial period (from signing the ICF to 6 months after the...
What rules you out
- Having been previously exposed to any anti-TIGIT, PD-1, PD-L1 or CTLA-4 drugs;
- Having suffered from other malignant tumors and currently requiring treatment (except for cervical carcinoma in situ, basal cell carcinoma or squamous cell carcinoma of the skin that have been adequately treated);
- Having an autoimmune disease or a history of autoimmune diseases or related symptoms;
- people who cannot undergo MRI (such as those with a pacemaker implanted, non-removable metal dentures, claustrophobia, etc.);
- people who have received chemotherapy (those who have used nitrosourea drugs within 42 days before the first receipt of the experimental drug cannot be enrolled), radiotherapy, biotherapy, endocrine therapy, targeted...
- people with tumor lesions involving the brainstem, spinal cord or leptomeningeal dissemination and metastasis;
- Those who have used corticosteroids within 1 month before participating in the trial and have received systemic treatment with a daily dose higher than 3 mg of dexamethasone or an equivalent dose of other hormones;
- The toxicity caused by previous anti-tumor treatments has not decreased to ≤ grade 1 as defined in CTCAE version 5.0 (except for toxicities judged by the investigator to have no safety risks, such as alopecia, grade 2...
- Those who have received live attenuated vaccines within 4 weeks before the first administration of the study drug or plan to receive them during the study period;
- people with active infections at present (such as acute bacterial infections, tuberculosis, pulmonary infections, etc.);
- Those who are positive for hepatitis B core antibody (HBcAb) or hepatitis B surface antigen (HBsAg), and whose HBV DNA is higher than the upper limit of the normal value of the site, or those judged by doctors to have...
- Those with cardiac clinical symptoms or diseases that are not well controlled, such as uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg), unstable angina pectoris...
- Cardiac function classified as grade III or IV according to the New York Heart Association (NYHA) classification;
- Those who are allergic to the components or excipients of the experimental drug, antibody drugs or any other therapeutic proteins (such as fresh frozen plasma, human serum albumin, cytokines or interleukins, etc.), or...
- Those with a clear history of neurological or mental disorders in the past, such as dementia, and with poor compliance;
- Those with epilepsy and/or increased intracranial pressure that are difficult to control by drugs;
- Pregnant or lactating women;
- Other situations that the investigator deems unsuitable for participating in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, 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 Beijing, Beijing Municipality, 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.