Diffuse Large B-Cell Lymphoma
Conditions
Brief summary
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.
Interventions
DRUGBL-M08D1
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGRituximab
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGGemcitabine Hydrochloride
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGOxaliplatin
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGCyclophosphamide
Administration by intravenous infusion for a cycle of 3 weeks.
Administration by intravenous infusion for a cycle of 3 weeks.
DRUGVincristine Sulfate
Administration by intravenous infusion for a cycle of 3 weeks.
Oral administration for a cycle of 3 weeks.
Sponsors
Sichuan Baili Pharmaceutical Co., Ltd.
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recommended Phase II Dose (RP2D) | Up to approximately 24 months | The RP2D is defined as the dose level chosen by the sponsor (in consultation with the investigators) for phase II study, based on safety, tolerability, efficacy, PK, and PD data collected during the dose escalation study of BL-M08D1. |
| Objective Response Rate (ORR) | Up to approximately 24 months | ORR is defined as the percentage of participants, who has a CR (disappearance of all target lesions) or PR (at least a 30% decrease in the sum of diameters of target lesions). The percentage of participants who experiences a confirmed CR or PR is according to RECIST 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate (CRR) | Up to approximately 24 months | Complete Remission Rate (CRR) refers to the proportion of patients in a clinical trial who achieve a complete remission (CR) after receiving a specific treatment. |
| Progression-free Survival (PFS) | Up to approximately 24 months | Progression-free survival (PFS) as assessed by BICR is defined as the time between the date subjects were randomized and the first observation of disease progression (based on BICR's image-based assessment) or death. |
| Disease Control Rate (DCR) | Up to approximately 24 months | Disease Control Rate (DCR) : Percentage of all randomized subjects who rated the best overall response (BOR) as complete response (CR), partial response (PR), and disease stabilization (SD) according to RECIST 1.1 criteria. |
| Duration of Response (DOR) | Up to approximately 24 months | Duration of Response (DOR) is defined as the period from the date when tumor response is first recorded to the date when objective tumor progression is first recorded or the date of death. |
| Treatment-Emergent Adverse Event (TEAE) | Up to approximately 24 months | TEAE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally emerging, or any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition during the treatment of BL-M08D1 . The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M08D1. |
Countries
China
Contacts
CONTACTSa Xiao, PHD
Outcome results
None listed