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
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
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.