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

Sichuan Baili Pharmaceutical

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Venetoclax; Drug: Azacitidine; Drug: Cytarabine; Drug: Daunorubicin; Drug: BL-M11D1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07255872

BL-M11D1-201

Details and patient eligibility

About

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 newly diagnosed acute myeloid leukemia.

Full description

The study cohorts include: Cohort A: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with cytarabine + daunorubicin. Cohort B: Untreated newly diagnosed acute myeloid leukemia patients treated with BL-M11D1 in combination with venetoclax + azacitidine.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Voluntarily sign the informed consent form and comply with the protocol requirements;
2. No gender restrictions;
3. Age: ≥18 years;
4. Expected survival time ≥3 months;
5. Newly diagnosed AML according to the World Health Organization (WHO) 2016 classification and confirmed by morphology;
6. ECOG performance status score ≤2;
7. Peripheral blood white blood cell count ≤25×10⁹/L before the first dose;
8. Organ function levels must meet the requirements;
9. For premenopausal women with childbearing potential, a pregnancy test must be performed within 7 days before starting treatment, and the serum/urine pregnancy test must be negative. Patients must not be breastfeeding; all enrolled patients (regardless of male or female) should adopt adequate barrier contraception throughout the entire treatment cycle and for 6 months after the end of treatment.

Exclusion criteria

1. Acute promyelocytic leukemia, acute transformation of chronic myeloid leukemia;
2. Previous treatment for AML;
3. Participation in other interventional or observational studies;
4. History of severe cardiovascular or cerebrovascular diseases within 6 months prior to screening;
5. Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia;
6. Active autoimmune diseases and inflammatory diseases;
7. Diagnosis of other malignancies within 5 years prior to the first dose;
8. Poorly controlled hypertension;
9. Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc.;
10. Patients with central nervous system involvement;
11. Previous organ transplantation;
12. History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M11D1;
13. Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
14. Evidence of other clinically significant, poorly controlled infections requiring systemic treatment;
15. Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage;
16. Previous treatment with cytarabine, methylating agents, or investigational drugs for MDS;
17. Pregnant or lactating women;
18. Within 4 weeks prior to the first dose of the study drug, subjects must not have received any live vaccines or are not expected to receive live vaccines during the study participation;
19. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

BL-M11D1 in Combination with Cytarabine + Daunorubicin or Venetoclax + Azacitidine

Experimental group

Description:

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.

Treatment:

Drug: Daunorubicin

Drug: BL-M11D1

Drug: Cytarabine

Drug: Azacitidine

Drug: Venetoclax