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

Официальное название

A Phase II/III Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of BL-M11D1 for Injection in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Objective Response Rate (ORR) [Срок оценки: Up to approximately 24 months]
• Composite Response Rate（CRc） [Срок оценки: Up to approximately 24 months]
• Phase IIa: Recommended Phase II Dose (RP2D) [Срок оценки: Up to approximately 24 months]

Вторичные конечные точки (8)

• Progression-free survival (PFS) [Срок оценки: Up to approximately 24 months]
• Disease Control Rate (DCR) [Срок оценки: Up to approximately 24 months]
• Relapse-Free Survival (RFS) [Срок оценки: Up to approximately 24 months]
• Treatment-Emergent Adverse Event (TEAE) [Срок оценки: Up to approximately 24 months]
• Cmax [Срок оценки: Up to approximately 24 months]
• Tmax [Срок оценки: Up to approximately 24 months]
• Ctrough [Срок оценки: Up to approximately 24 months]
• ADA (anti-drug antibody) [Срок оценки: Up to approximately 24 months]

Критерии участия

Критерии включения

• Voluntarily sign the informed consent form and comply with the protocol requirements;
• No gender restrictions;
• Age: ≥18 years;
• Expected survival time ≥3 months;
• Newly diagnosed AML according to the World Health Organization (WHO) 2016 classification and confirmed by morphology;
• ECOG performance status score ≤2;
• Peripheral blood white blood cell count ≤25×10⁹/L before the first dose;
• Organ function levels must meet the requirements;
• 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.

Критерии исключения

• 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;
• Prolonged QT interval, complete left bundle branch block, third-degree atrioventricular block, frequent and uncontrollable arrhythmia;
• Active autoimmune diseases and inflammatory diseases;
• Diagnosis of other malignancies within 5 years prior to the first dose;
• Poorly controlled hypertension;
• Grade ≥3 lung disease as defined by CTCAE v5.0, history of interstitial lung disease requiring systemic steroid therapy, etc.;
• Patients with central nervous system involvement;
• Previous organ transplantation;
• History of allergy to recombinant humanized antibodies or human-mouse chimeric antibodies, or allergy to any excipient component of BL-M11D1;
• Positive human immunodeficiency virus antibody, active tuberculosis, active hepatitis B virus infection, or active hepatitis C virus infection;
• Evidence of other clinically significant, poorly controlled infections requiring systemic treatment;
• Clinically symptomatic or recurrent pleural, peritoneal, pelvic, or pericardial effusion requiring drainage;
• Pregnant or lactating women;
• 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;
• Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences — Тяньцзинь

Идентификаторы

NCT: NCT07255872 · BL-M11D1-201

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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