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

Prior treatment

• Use of chemotherapy, biological therapy, immunotherapy, etc., within 4 weeks or 5 half-lives prior to the first dose;
• History of severe heart disease or cerebrovascular disease within 6 months before screening;
• Diagnosis of active malignancy within 5 years prior to the first dose;
• Unstable thrombotic events requiring therapeutic intervention within 6 months prior to the first dose;
• Concurrent pulmonary diseases resulting in clinically severe impairment of respiratory function;
• Previous or current central nervous system disorders;
• Contraindications to any component of the study intervention, including but not limited to previous allergic reactions;
• Receipt of autologous hematopoietic stem cell transplantation or CAR-T cell therapy, etc., within 12 weeks prior to the first dose;
• Active infection requiring systemic therapy within 4 weeks prior to the first study drug administration;
• 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;
• Use of another investigational drug within 4 weeks or 5 half-lives prior to the first dose;

Other illness

• Active autoimmune diseases and inflammatory diseases;
• Hypertension inadequately controlled by antihypertensive medications;
• History of interstitial lung disease requiring corticosteroid therapy, or current ILD, or radiation pneumonitis of grade ≥2;
• Positive for human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• 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;
• Other conditions that, in the investigator's opinion, make the participant unsuitable for enrollment in this clinical trial.

Lab values

• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
• Trial participants with poorly controlled blood glucose;

Other

• Use of glucocorticoids at a dose \>30 mg/day prednisone or equivalent, for purposes other than control of lymphoma symptoms;
• Patients with central nervous system involvement;
• Pregnant or breastfeeding women;

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restriction;
• Age ≥18 years and ≤75 years;
• Expected survival time ≥3 months;
• Patients with diffuse large B-cell lymphoma;
• Agree to provide archived tumor tissue specimens within 3 years or fresh tissue samples;
• Must have at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) performance status score ≤2;
• Toxicity from prior anti-tumor therapy must have recovered to ≤ Grade 1 as defined by NCI-CTCAE v6.0;
• No severe cardiac dysfunction, with left ventricular ejection fraction ≥50%;
• Organ function levels must meet the requirements;
• Urine protein ≤1+ or \<1000 mg/24h;
• 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;
• 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.