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 (Jun 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
Treatments studied
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06118788 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior CAR-T cell therapy, hematopoietic stem cell transplantation disqualifies patients from enrollment.
Does this trial require CLEC12A?
Yes, CLEC12A overexpression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 70 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