OncoMatch

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.

Phase 1/2RecruitingGuangzhou Bio-gene Technology Co., LtdNCT06118788Data as of May 2026

Treatment: BG1805This is a single-arm, single-dose dose-escalation and dose-expansion study.

Check if I qualify

Extracted 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

Min 1 prior line

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.

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