BG1805 Injection in the Treatment of Relapsed or Refractory Acute Myeloid Leukemia in Children

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age3-18
SponsorGuangzhou Bio-gene Technology Co., Ltd

About this trial

This is a single-arm, single-dose dose-escalation and dose-expansion study.

Eligibility criteria

Qualifiers

Voluntarily sign the informed consent and be expected to complete the follow-up examination and treatment of the study procedures. Subject, parent or legal guardian sign and date the informed consent form.

Age of 3-18 years old (inclusive of the cut-off value), regardless of gender and weight ≥10 kg.

Relapsed AML diagnostic criteria: the reappearance of peripheral blood or bone marrow blasts after complete remission (CR); 5% (excluding other causes such as bone marrow regrowth after consolidation chemotherapy) or extramedullary leukemic cell infiltration.

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.

Disqualifiers

Acute promyelocytic leukemia was diagnosed.

Have other malignant tumors within 3 years before screening, excluding adequately treated cervical carcinoma in situ, papillary thyroid carcinoma, basal cell or squamous cell skin cancer, local prostate cancer after radical prostatectomy, and ductal carcinoma in situ after radical prostatectomy.

Evidence of central nervous system involvement or cranial neuropathy.

Hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive and peripheral blood HBV-DNA higher than the detection limit; Hepatitis C virus (HCV) antibody positive; Persons with human immunodeficiency virus (HIV) antibody positive; Cytomegalovirus (CMV) DNA positive cases; EBV-DNA positive patients; The syphilis antibody was positive.

Trial design

Treatments tested in this trial

  • BG1805

Treatment groups

24 Participants
are divided into 1 treatment group

Locations

This trial has no locations