Tests BL-M08D1 with immunochemotherapy in diffuse large B-cell lymphoma
Tests BL-M08D1 added to immunochemotherapy in adults with diffuse large B-cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Study of BL-M08D1 in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma
Key facts
- Where
- Guangzhou and Suzhou, ChinaSee the 2 sites
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07818499, who can take part
Where in China
- Sun Yat-sen University Cancer CenterGuangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Soochow UniversitySuzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sichuan Baili Pharmaceutical Co., Ltd.
- Trial code
- NCT07818499
- Record updated
- 14 September 2026
- Original description
This Phase Ib/II study is a clinical trial to explore the efficacy and safety of BL-M08D1 for injection in combination with immunochemotherapy in patients with diffuse large B-cell lymphoma.Read full original descriptionShow less
A Phase Ib/II Clinical Study to Evaluate the Efficacy and Safety of BL-M08D1 for Injection in Combination With Immunochemotherapy in Patients With Diffuse Large B-Cell Lymphoma
This Phase Ib/II study is a clinical trial to explore the efficacy and safety of BL-M08D1 for injection in combination with immunochemotherapy in patients with diffuse large B-cell lymphoma.
Inclusion: 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.
Exclusion: 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; 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; Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias; Trial participants with poorly controlled blood glucose; 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.