BL-M11D1 for Relapsed/Refractory Acute Myeloid Leukemia
This study is testing a new drug called BL-M11D1 for people with acute myeloid leukemia (AML) that has come back (relapsed) or hasn't responded to previous treatments (refractory). The main goals are to see how safe BL-M11D1 is, how well your body handles it, and if it shows any signs of helping to treat the leukemia. You might be able to join if you are 18 or older, have a life expectancy of at least 3 months, and your AML has a specific marker called CD33. The study aims to enroll about 120 participants and is currently unclear if it's recruiting.
- Study design
- This is a multi-center study with two parts: dose escalation and dose finding. It plans to enroll about 120 participants.
- What's involved
- You would receive BL-M11D1 on specific days within continuous 28-day treatment cycles, depending on which group you are in.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be monitored for dose-limiting toxicities, serious adverse events, and treatment-emergent adverse events for up to 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
At a glance
Conditions
Where it's being run
18 sites across 15 statesStudy leadership
- Olu Lawson · STUDY_DIRECTOR · SystImmune Inc.
Who to contact
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What this trial measures
- Participants with dose-limiting toxicities1 Year
DLTs are defined as any of the following events that are not clearly due to the underlying disease, disease progression, or extraneous causes: * Any treatment-emergent adverse event (TEAE) of ≥ Grade 3 except those due to disease progression or extraneous cause * Any TEAE that leads to dose reduction or withdrawal Nonhematologic toxicities * Death * Hy's law cases * Grade ≥3 nonhematologic toxicities (with exceptions) Hematologic toxicity * Grade 4 thrombocytopenia or neutropenia lasting \>42 days in the absence of persistent leukemia * Grade ≥3 platelet count decreased with clinically significant hemorrhage
- Participants with Serious Adverse Events (SAEs) and treatment-emergent adverse events (TEAEs)1 Year
Measuring the number of patients with serious adverse events (SAEs) and treatment-emergent adverse events (TEAEs)
- To determine the minimum safe and effective dose (MSED), maximum tolerated dose (MTD) if reached, and maximum administered dose (MAD) of BL-M11D1 in AML1 Year
Determine the highest BL-M11D1 dose level at which ≤33% subjects experience a DLT during the DLT evaluation period and highest BL-M11D1 dose administered in the event and MTD cannot be defined.