A Study of BL-B01D1 in Patients With Recurrent Glioblastoma

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 definedby 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 factorand/or platelet-raising drugs are allowed within 14 days before the first dose ofstudy drug, and the organ function level must meet the requirements;

10. Coagulation function: international normalized ratio (INR) ≤1.5, and activatedpartial 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 forpremenopausal women who are likely to have children, the serum or urine pregnancytest must be negative, and the patient must not be lactating; All enrolled patientsshould 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 weeksor 5 half-lives before the first dose, small molecule targeted therapy had been usedwithin 5 days, palliative radiotherapy, modern Chinese medicine preparationsapproved by NMPA for anti-tumor treatment had been used within 2 weeks;

2. A history of central nervous system hemorrhage/infarction requiring treatmentunrelated 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 degreeatrioventricular block, severe arrhythmia;

5. Unstable thrombotic events requiring therapeutic intervention within 6 months beforescreening; Infusion-related thrombosis was excluded;

6. Active autoimmune and inflammatory diseases;

7. Other malignant tumors that progressed or required treatment within 5 years beforethe first dose;

8. Hypertension poorly controlled by two antihypertensive drugs (systolic bloodpressure > 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 radiationpneumonitis, or suspected to have such disease by imaging during screening;

11. Complicated with pulmonary diseases leading to clinically severe respiratoryfunction impairment;

12. Patients with a history of allergy to recombinant humanized or human-mouse chimericantibodies or to any of the excipients of BL-B01D1;

13. Received previous organ transplantation or allogeneic hematopoietic stem celltransplantation (Allo-HSCT);

14. Human immunodeficiency virus antibody positive, active tuberculosis, activehepatitis 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 ofstudy drug;

16. Imaging examination indicated that the tumor had invaded or enveloped the largevessels of the chest, neck, and pharynx, except for those that the investigatorthought would not affect the patient's enrollment in the drug;

17. Other circumstances that the investigator deemed inappropriate for participation inthe trial.