A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma

Inclusion Criteria:

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. No gender restriction;
3. Age ≥18 years and ≤75 years;
4. Expected survival time ≥3 months;
5. Patients with diffuse large B-cell lymphoma;
6. Agree to provide archived tumor tissue specimens within 3 years or fresh tissue samples;
7. Must have at least one measurable lesion;
8. Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
9. Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
10. No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
11. Organ function levels must meet the requirements;
12. Urine protein ≤1+ or <1000 mg/24h;
13. For premenopausal women with childbearing potential, a serum pregnancy test must be performed within 7 days before starting treatment, and the serum pregnancy test must exclude pregnancy; patients must not be breastfeeding; all enrolled trial participants must take adequate barrier contraceptive measures throughout the entire treatment period and for 6 months after treatment completion;
14. Trial participants must be able and willing to comply with the visit schedule, treatment plan, laboratory tests, and other study-related procedures specified in the protocol.

Exclusion Criteria:

1. Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
2. History of severe heart disease or cerebrovascular disease within 6 months before screening;
3. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
4. Active autoimmune diseases and inflammatory diseases;
5. Diagnosis of active malignancy within 5 years prior to the first dose;
6. Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
7. Hypertension inadequately controlled by antihypertensive medications;
8. Trial participants with poorly controlled blood glucose;
9. History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of grade ≥2;
10. Use of glucocorticoids at a dose >30 mg/day prednisone or equivalent, for purposes other than control of lymphoma symptoms;
11. Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
12. Patients with central nervous system involvement;
13. Previous or current central nervous system disorders;
14. Contraindications to any component of the study intervention, including but not limited to previous allergic reactions;
15. Receipt of autologous hematopoietic stem cell transplantation or CAR-T cell therapy, etc., within 12 weeks prior to the first dose;
16. Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
17. Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
18. Pleural, abdominal, or pelvic effusion or pericardial effusion requiring drainage and/or accompanied by symptoms within 4 weeks prior to the first study drug administration;
19. Imaging findings indicating that the tumor has invaded or encased major blood vessels in the abdomen, chest, neck, pharynx, etc., or the pericardium or heart;
20. Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;
21. Pregnant or breastfeeding women;
22. Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in this clinical trial.