A Study of BL-B01D1 in Patients With Recurrent Glioblastoma

Launched by SICHUAN BAILI PHARMACEUTICAL CO., LTD. · Sep 12, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called BL-B01D1 for patients with recurrent glioblastoma, a type of brain cancer that has come back after standard treatments. The trial aims to evaluate how safe the treatment is and how well it works. It is currently open for enrollment, meaning they are looking for participants, and people aged 18 and older can join. To be eligible, participants must have a confirmed diagnosis of recurrent glioblastoma, must have had previous treatments that didn't work, and should be in good enough health to tolerate the study drug.

If you decide to participate, you’ll receive the treatment at a participating location and be monitored closely for any side effects or changes in your condition. It’s important to know that there are certain health conditions that might prevent someone from joining, such as severe heart issues or recent serious infections. Additionally, women of childbearing age will need to confirm they are not pregnant before starting the treatment. This trial could offer a new option for those facing recurrent glioblastoma, and your involvement could help improve treatment for others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sign the informed consent form voluntarily and follow the protocol requirements;
• • 2. Gender is not limited;
• • 3. Age: ≥18 years old;
• • 4. Recurrent glioblastoma confirmed by pathology after failure of standard treatment;
• • 5. KPS≥60;
• • 6. The expected survival time as judged by the investigator was ≥3 months;
• • 7. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as defined by NCI-CTCAE v5.0;
• • 8. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;
• • 9. 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;
• • 10. Coagulation function: international normalized ratio (INR) ≤1.5, and activated partial thromboplastin time (APTT) ≤1.5ULN;
• • 11. Urine protein ≤2+ or \< 1000mg/24h;
• • 12. 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 Criteria:
• • 1. 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;
• • 2. A history of central nervous system hemorrhage/infarction requiring treatment unrelated to antineoplastic drugs within 6 months before enrollment;
• • 3. History of severe heart disease and cerebrovascular disease;
• • 4. Prolonged QT interval, complete left bundle branch block, III degree atrioventricular block, severe arrhythmia;
• • 5. Unstable thrombotic events requiring therapeutic intervention within 6 months before screening; Infusion-related thrombosis was excluded;
• • 6. Active autoimmune and inflammatory diseases;
• • 7. Other malignant tumors that progressed or required treatment within 5 years before the first dose;
• • 8. Hypertension poorly controlled by two antihypertensive drugs (systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 100 mmHg);
• • 9. Patients with poor glycemic control or with diabetic gangrene;
• • 10. Patients with a previous history of ILD, or current ILD or ≥G2 radiation pneumonitis, or suspected to have such disease by imaging during screening;
• • 11. Complicated with pulmonary diseases leading to clinically severe respiratory function impairment;
• • 12. Patients with a history of allergy to recombinant humanized or human-mouse chimeric antibodies or to any of the excipients of BL-B01D1;
• • 13. Received previous organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT);
• • 14. Human immunodeficiency virus antibody positive, active tuberculosis, active hepatitis B virus infection or active hepatitis C virus infection;
• • 15. 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;
• • 16. 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;
• • 17. Other circumstances that the investigator deemed inappropriate for participation in the trial.