A Study of BL-M08D1 in Patients With Relapsed or Refractory Lymphoid Malignancies

Inclusion Criteria:

1. Sign the informed consent form voluntarily and follow the protocol requirements;

2. Gender is not limited;

3. Age: ≥18 years old and ≤75 years old;

4. Expected survival time ≥3 months;

5. Recurrent or refractory lymphoid malignancies confirmed by histopathology and/orcytology that are incurable or for which no standard treatment is currentlyavailable;

6. Consent to provide archival tumor tissue samples or fresh tissue samples fromprimary or metastatic lesions within 2 years;

7. ECOG≤2;

8. The toxicity of previous antineoplastic therapy has returned to ≤ grade 1 as definedby NCI-CTCAE v5.0;

9. No severe cardiac dysfunction, left ventricular ejection fraction ≥50%;

10. Organ function level must meet the requirements;

11. Coagulation function: international normalized ratio (INR) ≤1.5, and activatedpartial thromboplastin time (APTT) ≤1.5ULN;

12. Urinary protein ≤2+ or ≤1000mg/24h;

13. For premenopausal women of childbearing potential, a pregnancy test must beperformed within 7 days before the initiation of treatment, serum pregnancy must benegative, and the patient must not be lactating; All enrolled patients (regardlessof male or female) should use adequate barrier contraception during the wholetreatment cycle and for 6 months after the end of treatment;

14. Subjects were able and willing to comply with protocol-specified visits, treatmentplans, laboratory tests, and other study-related procedures.

Exclusion Criteria:

1. Chemotherapy, biological therapy and other anti-tumor therapies have been usedwithin 4 weeks or 5 half-lives before the first dose; Palliative radiotherapy ortraditional Chinese medicine with anti-tumor indications within 2 weeks before thefirst dose;

2. History of severe heart disease;

3. QT prolongation, complete left bundle branch block, III degree atrioventricularblock;

4. Active autoimmune and inflammatory diseases;

5. Other malignant tumors diagnosed within 5 years before the first dose;

6. Hypertension poorly controlled by two antihypertensive drugs (systolic bloodpressure > 150 mmHg or diastolic blood pressure > 100 mmHg);

7. Patients with poor glycemic control or with diabetic gangrene;

8. A history of ILD requiring steroid therapy or current ILD or grade ≥2 radiationpneumonitis;

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

10. Patients with central nervous system involvement;

11. Had a history of or central nervous system disease;

12. Patients with a history of allergy to recombinant humanized antibody or human-mousechimeric antibody or to any component of BL-M08D1 excipients;

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. Active infection requiring systemic therapy within 4 weeks before the first dose ofstudy drug;

16. Pleural, abdominal, pelvic or pericardial effusion requiring drainage and/or withsymptoms within 4 weeks before the first dose of study drug;

17. Received another trial drug 4 weeks or 5 half-lives before the first dose;

18. Pregnant or lactating women;

19. Other conditions for participation in the trial were not considered appropriate bythe investigator.