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.
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;
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;
Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, or frequent and uncontrolled arrhythmias;
Active autoimmune diseases and inflammatory diseases;
Parallel
BL-M08D1
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Rituximab
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Gemcitabine Hydrochloride
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Oxaliplatin
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Cyclophosphamide
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Doxorubicin Hydrochloride Liposome
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Vincristine Sulfate
DrugAdministration by intravenous infusion for a cycle of 3 weeks.
Prednisone Acetate Tablets
DrugOral administration for a cycle of 3 weeks.
Recommended Phase II Dose (RP2D)
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)
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.
Complete Remission Rate (CRR)
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)
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)
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)
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.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
