The purpose of this single- arm, open-label, dose escalation and dose expansion phase I/II study is to evaluate the safety, tolerability, pharmacokinetic and preliminary efficacy of TGRX-814 in patients with hematological malignancies including non-Hodgkin lymphoma, acute myeloid leukemia, aute lymphoblastic leukemia and myelodysplastic syndromes.
male or female ≥ 18 years of age
fully understand the requirements of the study and voluntarily sign a written informed consent form
diagnosis of NHL, ALL, AML or MDS
Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2
received BCL-2 inhibitor therapy prior to the first dose of study drug, unless discontinued due to intolerance
subjects with NHL have been diagnosed with Burkitt's lymphoma, lymphoblastoid lymphoma/leukemia, or post-transplant lymphoproliferative disease (PTLD)
AML subjects with a diagnosis of acute promyelocytic leukemia or Ph chromosome positive or persistent extramedullary leukemia
tumor infiltration of the central nervous system
Shenzhen TargetRx Co., Ltd.
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborator