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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
BG1805
Biological/VaccineA single infusion of BG1805 Injection administered intravenously.
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: BG1805Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
1.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.
Time frame
Up to 28 days after BG1805 infusion.2
2.Incidence of Treatment-Emergent Adverse Events
Count the Incidence of adverse events.
Time frame
Up to 24 months.Secondary outcomes
1
3.Concentration of CAR-T cells after Infusion (PK)
CAR-T in peripheral blood after infusion
Time frame
Up to 24 months.2
4.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).
Time frame
Up to 24 months.3
5.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.
Time frame
Up to 24 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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