OncoMatch/Clinical Trials/NCT05924750
A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Is NCT05924750 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT05924750 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior antineoplastic therapy, allogeneic hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CD33?
Yes, CD33 overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages