A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Sponsor
Sichuan Baili Pharmaceutical Co., Ltd.
Study ID
NCT07255872
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BL-M11D1 — DRUG
    Administration by intravenous infusion for a cycle of 4 weeks.
  • Cytarabine — DRUG
    Administration in 4-week cycles.
  • Daunorubicin — DRUG
    Administration in 4-week cycles.
  • Venetoclax — DRUG
    Administration in 4-week cycles.
  • Azacitidine — DRUG
    Administration in 4-week cycles.

Study Details

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.

Key Dates

Start date
Mar 31, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
216 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine
    Participants receive BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine for the first cycle (4 weeks). Participants with clinical benefit could receive additional treatment for more cycles. The administration will be terminated because of disease progression or intolerable toxicity occurring or other reasons.

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to approximately 24 months ]

Central Contacts

Related Studies