RecruitingPhase 1NCT05924750

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of BL-M11D1 in Relapsed/Refractory Acute Myeloid Leukemia (AML) Patients


Sponsor

Sichuan Baili Pharmaceutical Co., Ltd.

Enrollment

130 participants

Start Date

Aug 2, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Ia: To observe the safety and tolerability of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia to determine the maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) of BL-M11D1. Ib: Further observe the safety and tolerability of BL-M11D1 at the recommended dose in phase Ia to determine the recommended dose in phase II clinical study (RP2D).


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called BL-M11D1 — an antibody-drug conjugate that targets a protein called CD33 found on leukemia cells — in patients with acute myeloid leukemia (AML, a blood cancer) that has come back or stopped responding to prior treatment. The drug attaches to CD33-positive cancer cells and delivers a toxic payload directly to them. **You may be eligible if:** - You are 18–75 years old - You have been diagnosed with acute myeloid leukemia (AML) that is CD33-positive on lab testing - Your leukemia has relapsed or is no longer responding to previous treatments (relapsed/refractory AML) - Your bone marrow has at least 5% blast cells (immature cancer cells) - You are in reasonably good health (ECOG 0–2) with a life expectancy of at least 3 months - Your white blood cell count is below 25×10⁹/L before the first dose - Your organ function meets the study requirements **You may NOT be eligible if:** - You have acute promyelocytic leukemia (a specific AML subtype) or AML transformed from chronic myeloid leukemia - You have received another anti-cancer treatment within 4 weeks (or within 5 half-lives) before starting the study drug - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBL-M11D1

Administration by intravenous infusion


Locations(8)

Anhui Provincial Hospital

Hefei, Anhui, China

Beijing Hospital

Beijing, Beijing Municipality, China

Institute of Hematology, the First Hospital of Harbin

Haerbin, Heilongjiang, China

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shangdong, China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

West China Hospital,Sichuan University

Chengdu, Sichuan, China

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

Tianjin, Tianjin Municipality, China

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NCT05924750


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