OncoMatch/Clinical Trials/NCT05924750
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT05924750 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M11D1 for relapsed/refractory acute myeloid leukemia (r/r aml).
Treatment: BL-M11D1 — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD33 overexpression
CD33-positive relapsed/refractory acute myeloid leukemia (AML)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: antineoplastic therapy
Antineoplastic therapy, including chemotherapy, biologic therapy, immunotherapy, definitive radiotherapy, major surgery (investigator-defined), or targeted therapy (including small-molecule tyrosine kinase inhibitors), has been administered within 4 weeks or 5 half-life cycles (whichever is shorter) before the first dose; Or palliative radiotherapy within 2 weeks before the first dose
Cannot have received: allogeneic hematopoietic stem cell transplantation
Prior organ transplantation or allogeneic hematopoietic stem cell transplantation (Allo-HSCT)
Lab requirements
Blood counts
Peripheral blood white blood cell count ≤25×10^9/L before the first dose; Morphological assessment showing ≥5% blasts in the bone marrow
Kidney function
Organ function levels meet the requirements within 7 days before the first dose
Liver function
Organ function levels meet the requirements within 7 days before the first dose
Cardiac function
No history of severe heart disease, such as left ventricular ejection fraction < 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of myocardial infarction, unstable angina, etc.; No prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, and III degree atrioventricular block
Organ function levels meet the requirements within 7 days before the first dose; Peripheral blood white blood cell count ≤25×10^9/L before the first dose; Morphological assessment showing ≥5% blasts in the bone marrow; History of severe heart disease, such as left ventricular ejection fraction < 50%, history of symptomatic congestive heart failure (CHF) ≥ grade 2 (CTCAE v5.0), New York Heart Association (NYHA) ≥ grade 2 heart failure, history of myocardial infarction, unstable angina, etc. [excluded]; Prolonged QT interval (QTc > 450 msec in men or QTc > 470 msec in women), complete left bundle branch block, and III degree atrioventricular block [excluded]
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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