OncoMatch/Clinical Trials/NCT06118788
Phase I Clinical Study: BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Is NCT06118788 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies BG1805 for leukemia, myeloid, acute.
Treatment: BG1805 — This is a single-arm, single-dose dose-escalation and dose-expansion study.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CLEC12A overexpression (≥50%)
Flow cytometry confirmed the AML Blast CLL-1 expression positive (CLL-1 expression ≥50%)
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard chemotherapy
Refractory AML diagnostic criteria: newly diagnosed patients who failed to response to 2 courses of standard regimens; Patients who relapsed within 12 months after consolidation and intensive therapy; Patients relapsed after 12 months but failed to respond to conventional chemotherapy; Patients with two or more recurrences; Patients with persistent extramedullary leukemia.
Cannot have received: CAR-T cell therapy
Subjects who have received other CAR-T therapy or cell therapy in the past.
Cannot have received: hematopoietic stem cell transplantation
Exception: within 6 months before screening
Patients who had undergone hematopoietic stem-cell transplantation within 6 months before screening.
Lab requirements
Blood counts
hemoglobin ≥60g/L or maintained at that level after transfusion
Kidney function
serum creatinine ≤1.5x ULN or creatinine clearance ≥60 mL/min
Liver function
AST ≤3x ULN, ALT ≤3x ULN, total bilirubin ≤1.5x ULN
Cardiac function
LVEF ≥45%
Aspartate aminotransferase (AST) ≤3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤3 times ULN; Total bilirubin ≤1.5 times ULN; Serum creatinine ≤1.5 times ULN or creatinine clearance ≥60 mL/ minute; Hemoglobin ≥60g/L or maintained at that level after transfusion; Left ventricular ejection fraction (LVEF) ≥45%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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