Actively Recruiting
A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Led by Sichuan Baili Pharmaceutical Co., Ltd. · Updated on 2025-05-07
20
Participants Needed
1
Research Sites
102 weeks
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
This is an open-label, multicenter, phase II study to evaluate the safety, efficacy, and pharmacokinetic characteristics of BL-B01D1 for Injection in patients with recurrent glioblastoma.
CONDITIONS
Official Title
A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent voluntarily and agree to follow the study protocol
- Any gender
- Age 18 years or older
- Recurrent glioblastoma confirmed by pathology after failure of standard treatment
- Karnofsky Performance Score (KPS) of 60 or higher
- Expected survival time of 3 months or more as judged by the investigator
- Toxicity from previous cancer treatments has returned to grade 1 or less per NCI-CTCAE v5.0
- No severe cardiac dysfunction; left ventricular ejection fraction 50% or higher
- No blood transfusion, albumin, growth factors, or platelet-raising drugs within 14 days before first dose; organ function meets requirements
- Coagulation function within specified limits (INR ≤1.5, APTT ≤1.5 upper limit of normal)
- Urine protein ≤2+ or less than 1000 mg/24 hours
- Negative pregnancy test within 7 days before treatment for premenopausal women likely to conceive; not lactating
- Use of adequate barrier contraception during treatment and for 6 months after end of treatment
You will not qualify if you...
- Chemotherapy, biological therapy, immunotherapy, or small molecule targeted therapy within 4 weeks or 5 half-lives before first dose; palliative radiotherapy or certain Chinese medicine treatments within 2 weeks
- History of central nervous system hemorrhage or infarction requiring treatment unrelated to cancer drugs within 6 months
- History of severe heart disease or cerebrovascular disease
- Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or severe arrhythmia
- Unstable thrombotic events requiring treatment within 6 months (excluding infusion-related thrombosis)
- Active autoimmune or inflammatory diseases
- Other malignant tumors progressing or treated within 5 years before first dose
- Poorly controlled hypertension despite two antihypertensive drugs (systolic >150 mmHg or diastolic >100 mmHg)
- Poor glycemic control or diabetic gangrene
- History or current interstitial lung disease or grade 2 or higher radiation pneumonitis or suspected by imaging
- Severe pulmonary diseases causing significant respiratory impairment
- Allergy to humanized or human-mouse chimeric antibodies or BL-B01D1 excipients
- Previous organ or allogeneic hematopoietic stem cell transplantation
- Positive HIV antibody, active tuberculosis, or active hepatitis B or C infection
- Serious infection within 4 weeks or active pulmonary infection within 2 weeks before first dose
- Tumor invading or surrounding large chest, neck, or pharynx vessels, unless investigator approves
- Any other conditions deemed unsuitable by the investigator for trial participation
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, Capital Medical University
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
S
Sa Xiao, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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