Actively Recruiting
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Sichuan Baili Pharmaceutical Co., Ltd.
Lead Sponsor
B
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, effectiveness, and how the body processes BL-B01D1 for Injection in adults with recurrent glioblastoma, a type of brain cancer that has returned after standard treatment. This open-label, phase II study is being conducted at multiple centers and aims to provide important information about this treatment option for patients with this challenging condition. Participants receive BL-B01D1 through an intravenous infusion over a cycle lasting three weeks. Those who show clinical benefit may continue receiving additional treatment cycles. Treatment will stop if the disease progresses, intolerable side effects occur, or for other reasons determined by the study team. During the study, participants will be closely monitored for their response to treatment, including tumor response and disease control, as well as any side effects. Researchers will also assess how the drug moves through the body by measuring levels in the blood over approximately 24 months. Participants will undergo regular evaluations to track their progress and safety throughout the study period.
CONDITIONS
Brief Title
A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign the informed consent form and follow protocol requirements
- Any gender
- Age 18 years or older
- Recurrent glioblastoma confirmed by pathology after failure of standard treatment
- Karnofsky Performance Score 60 or higher
- Expected survival time of 3 months or more as judged by the investigator
- Previous antineoplastic therapy toxicity has returned to grade 1 or less (NCI-CTCAE v5.0)
- No severe cardiac dysfunction with left ventricular ejection fraction 50% or higher
- No blood transfusion, albumin, colony-stimulating factor, growth factors, or platelet-raising drugs within 14 days before first dose
- Coagulation function: INR 1.5 or less, APTT 1.5 times upper limit or less
- Urine protein 2+ or less or less than 1000 mg/24h
- Negative pregnancy test within 7 days before treatment for premenopausal women likely to have children
- Use adequate barrier contraception during treatment and for 6 months after end of treatment
You will not qualify if you...
- Use of chemotherapy, biological therapy, immunotherapy within 4 weeks or 5 half-lives before first dose
- Use of small molecule targeted therapy within 5 days before first dose
- Palliative radiotherapy or modern Chinese medicine for anti-tumor treatment within 2 weeks before first dose
- History of central nervous system hemorrhage or infarction requiring treatment unrelated to antineoplastic drugs within 6 months
- Severe heart disease or cerebrovascular disease history
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia
- Unstable thrombotic events requiring treatment within 6 months
- Active autoimmune or inflammatory diseases
- Other malignant tumors progressed or required treatment within 5 years
- Poorly controlled hypertension despite two drugs (systolic >150 mmHg or diastolic >100 mmHg)
- Poor glycemic control or diabetic gangrene
- History or presence of interstitial lung disease or grade 2 or higher radiation pneumonitis
- Severe pulmonary diseases causing respiratory impairment
- Allergy to recombinant humanized or human-mouse chimeric antibodies or any excipients of BL-B01D1
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Positive for HIV antibody, active tuberculosis, hepatitis B or C infection
- Serious infection within 4 weeks or active pulmonary infection within 2 weeks before first dose
- Tumor invading or enveloping large vessels of chest, neck, or pharynx that could affect enrollment
- Other conditions deemed inappropriate by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 3-week cycles until disease progression or discontinuation
Participants receive BL-B01D1 by intravenous infusion in cycles lasting 3 weeks. Those who benefit may receive additional cycles until disease progression, intolerable toxicity, or other reasons for stopping.
1 visit per cycle (in-person)
Trial Site Locations
Total: 1 location
1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
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