OncoMatch/Clinical Trials/NCT06714591
Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1
Is NCT06714591 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies BL-M11D1 for relapsed/refractory acute myeloid leukemia.
Treatment: BL-M11D1 — The objective of this study to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary efficacy of BL-M11D1 in patients with relapsed/refractory acute myeloid leukemia.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD33 positive (positive)
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: standard of care therapy
has failed initial standard of care therapy
Cannot have received: chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy
Chemotherapy, biological therapy, immunotherapy, radical radiotherapy, major surgery, targeted therapy (including small molecule inhibitor of tyrosine kinase), and other anticancer therapy within 2 weeks prior to the first administration
Cannot have received: mitomycin (mitomycin)
mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: nitrosoureas (nitrosoureas)
mitomycin and nitrosoureas treatment within 6 weeks prior to the first administration
Cannot have received: palliative radiotherapy
palliative radiotherapy within 2 weeks prior to the first administration
Cannot have received: investigational drug
Received an investigational drug within 2 weeks prior to first dose of study treatment.
Lab requirements
Kidney function
Creatinine clearance ≥50 mL/min (Cockcroft-Gault, CKD-Epi, or MDRD equations)
Liver function
Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN
Has adequate liver and renal function before registration, defined as: a. Hepatic function: Total bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for subjects with Gilbert's syndrome), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5×ULN b. Renal function: Creatinine clearance ≥50 mL/min (Cockcroft-Gault, Chronic Kidney Disease Epidemiology Collaboration [CKD-Epi], or Modification of Diet in Renal Disease Study [MDRD] equations)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope · Duarte, California
- UCLA Ronald Reagan Medical Center · Los Angeles, California
- Yale Cancer Center, Smilow Cancer Hospital at Yale New Haven · New Haven, Connecticut
- Moffitt Cancer Center · Tampa, Florida
- START Midwest/The Cancer and Hematology Center · Grand Rapids, Michigan
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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 qualify