This study is an open, multicenter, dose-escalation and expansion, non-randomized phase II/III clinical trial to evaluate the safety, tolerability, pharmacokinetic characteristics, and preliminary efficacy of BL-M11D1 in combination with cytarabine + daunorubicin or venetoclax + azacitidine in patients with acute myeloid leukemia.
Voluntarily sign the informed consent form and comply with the protocol requirements;
No gender restrictions;
Age: ≥18 years;
Expected survival time ≥3 months;
Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia;
Previous treatment for AML;
Participation in other interventional or observational studies;
History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
Single group
BL-M11D1
DrugAdministration by intravenous infusion for a cycle of 4 weeks.
Cytarabine
DrugAdministration in 4-week cycles.
Daunorubicin
DrugAdministration in 4-week cycles.
Venetoclax
DrugAdministration in 4-week cycles.
Azacitidine
DrugAdministration in 4-week cycles.
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.
Composite Response Rate（CRc）
CRc is defined as the proportion of patients who achieve any one of several pre-defined types of treatment response.
Phase IIa: 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-M11D1.
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)
The DCR is defined as the percentage of participants who has a CR, PR, or Stable Disease (SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease \[PD: at least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD\]).
Relapse-Free Survival (RFS)
Relapse-Free Survival (RFS) is defined as the time from randomization (or from the start of treatment for non-randomized studies) until the first occurrence of disease recurrence or death from any cause.
Treatment-Emergent Adverse Event (TEAE)
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-M11D1. The type, frequency and severity of TEAE will be evaluated during the treatment of BL-M11D1.
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Sichuan Baili Pharmaceutical Co., Ltd.
Lead sponsor
Baili-Bio (Chengdu) Pharmaceutical Co., Ltd.
Collaborator
