Actively Recruiting
BC008-1A Injection for Recurrent CNS WHO G4 Glioma
Led by Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd. · Updated on 2025-07-09
40
Participants Needed
1
Research Sites
86 weeks
Total Duration
On this page
Sponsors
S
Sichuan Luzhou Buchang Biopharmaceutical Co., Ltd.
Lead Sponsor
B
Beijing Tiantan Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
BC008-1A Injection for Recurrent CNS WHO G4 Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form
- Confirmed recurrent CNS WHO grade 4 glioma with disease progression after standard treatment and no surgical plan
- Male or female aged 18 years or older
- Expected survival time of at least 12 weeks
- At least one measurable intracranial tumor lesion according to RANO criteria
- Karnofsky Performance Status (KPS) of 70 or higher
- Adequate blood, liver, and kidney function meeting specified lab test criteria without recent growth factors or transfusions
- Agreement to use effective contraception during the trial if of childbearing potential
You will not qualify if you...
- Previous treatment with anti-TIGIT, PD-1, PD-L1, or CTLA-4 drugs
- Other active malignant tumors requiring treatment (except certain treated skin cancers and cervical carcinoma in situ)
- Autoimmune diseases or related symptoms
- Inability to undergo MRI (e.g., pacemaker, metal dentures, claustrophobia)
- Recent chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, tumor-treating fields therapy, immunotherapy, or anti-tumor Chinese patent medicines within specified time frames
- Tumor lesions involving brainstem, spinal cord, or leptomeningeal dissemination/metastasis
- Use of corticosteroids above specified dose within 1 month before trial
- Unresolved toxicities from previous treatments above grade 1 except specified conditions
- Recent live attenuated vaccines within 4 weeks before study drug or planned during study
- Active infections such as acute bacterial infections or tuberculosis
- Positive for certain hepatitis, HIV, or syphilis markers with active infection
- Uncontrolled cardiac conditions including hypertension, unstable angina, recent myocardial infarction, or arrhythmias
- Cardiac function NYHA class III or IV
- Allergy to study drug components or related therapeutic proteins, or history of severe allergic reactions
- History of neurological or mental disorders affecting compliance
- Difficult-to-control epilepsy or increased intracranial pressure
- Pregnant or breastfeeding women
- Other conditions deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
J
Jianing Wang
CONTACT
X
Xinlei Guo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here