This is a single-arm, single-dose dose-escalation and dose-expansion study.
Voluntarily sign the informed consent and be expected to complete the follow-up examination and treatment of the study procedures.
Age of 18-70 years old (inclusive of the cut-off value), regardless of gender.
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.
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.
Single group
BG1805
Biological/VaccineA single infusion of BG1805 Injection administered intravenously.
Dose Limited Toxicity Rate
After the infusion of BG1805, subjects still experienced adverse events, meeting the DLT definition, related to or possibly related to BG1805 infusion after optimal supportive treatment.
Incidence of Treatment-Emergent Adverse Events
Count the Incidence of adverse events.
Concentration of CAR-T cells after Infusion (PK)
CAR-T in peripheral blood after infusion
overall response rate, ORR
Defined as the proportion of subjects achieving complete response(CR), complete remission with incomplete blood cell recovery (CRi), morphologic leukemia-free state (MLFS), or partial response(PR).
Concentration of Cytokine after Infusion (PD)
Calculate the change of cytokine concentration in peripheral blood after After BG1805 infusion. Cytokines include IL-2、IL-6 and so on.
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