New drug BL-M08D1 joins standard therapy in fight against aggressive lymphoma

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.