Tests BL-B01D1 injection for returning glioblastoma brain tumors
Tests the BL-B01D1 injection in adults whose glioblastoma brain tumor has returned.
Plain-language title generated from the registry record
Registry title: A Study of BL-B01D1 in Patients With Recurrent Glioblastoma
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults whose glioblastoma, a brain tumour, has come back after standard treatment. They will receive the study drug BL-B01D1.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Recurrent glioblastoma confirmed by pathology after standard treatment has failed. KPS of 60 or higher, and expected survival of 3 months or more as judged by the investigator.
- Earlier treatment
- Standard treatment must have failed. Side effects of earlier cancer treatment must have settled to grade 1 or lower. No chemotherapy, biological therapy or immunotherapy within 4 weeks or 5 half-lives before the first dose.
Main reasons for not taking part
- HIV antibody positive, active tuberculosis, or active hepatitis B or C infection
- Past organ transplant or allogeneic stem-cell transplant
- Past or current interstitial lung disease (ILD) or radiation pneumonitis of grade 2 or higher
- Severe heart disease, heart rhythm problems, or stroke or brain bleeding in the past 6 months
- Allergy to humanized or human-mouse chimeric antibodies or to any ingredient of BL-B01D1
Read by machine on 9 November 2026.
Where in China
- Beijing Tiantan Hospital,Capital Medical UniversityBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT06598787
- Record updated
- 7 May 2025
- Original description
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.Read full original descriptionShow less
A Phase II Clinical Study to Evaluate the Efficacy and Safety of BL-B01D1 for Injection in Patients With Recurrent Glioblastoma
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.
Inclusion: Sign the informed consent form voluntarily and follow the protocol requirements; Gender is not limited; Age: ≥18 years old; Recurrent glioblastoma confirmed by pathology after failure of standard treatment; KPS≥60; The expected survival time as judged by the investigator was ≥3 months; The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0; No severe cardiac dysfunction, left ventricular ejection fraction ≥50%; No blood transfusion, albumin, colony-stimulating factor, any cell growth factor and/or platelet-raising drugs are allowed within 14 days before the first dose of study drug, and the organ function level must meet the requirements; Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN; Urine protein ≤2+ or < 1000mg/24h; A pregnancy test must be performed within 7 days before starting treatment for premenopausal women who are likely to have children, the serum or urine pregnancy test must be negative, and the patient must not be lactating; All enrolled patients should take adequate barrier contraception during the entire treatment cycle and for 6 months after the end of treatment.
Exclusion: Chemotherapy, biological therapy, immunotherapy, etc., had been used within 4 weeks or 5 half-lives before the first dose, small molecule targeted therapy had been used within 5 days, palliative radiotherapy, modern Chinese medicine preparations approved by NMPA for anti-tumor treatment had been used within 2 weeks; A history of central nervous system hemorrhage/infarction requiring treatment unrelated to antineoplastic drugs within 6 months before enrollment; Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded; Patients with a previous history of ILD, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such disease by imaging during screening; Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT); Had a serious infection within 4 weeks before the first dose of study drug; Indications of active pulmonary infection within 2 weeks before the first dose of study drug; Imaging examination indicated that the tumor had invaded or enveloped the large vessels of the chest, neck, and pharynx, except for those that the investigator thought would not affect the patient's enrollment in the drug; History of severe heart disease and cerebrovascular disease; Active autoimmune and inflammatory diseases; Other malignant tumors that progressed or required treatment within 5 years before the first dose; Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure > 150 mmHg or diastolic blood pressure > 100 mmHg); Complicated with pulmonary diseases leading to clinically severe respiratory function impairment; Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1; Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection; Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia; Patients with poor glycemic control or with diabetic gangrene; Other circumstances that the investigator deemed inappropriate for participation in the trial.