An Open Label, Dose-escalation, 12 weeks, Phase I Study to Evaluate Safety and Pharmacodynamics of Investigational Product (VT-Tri) after Allogeneic Stem Cell Transplantation in Patients with relapsed/refractory Acute Myeloid Leukemia (AML)

ViGenCell0 个研究点目标入组 9 人开始时间: 待定最近更新: 2022年3月8日

试验速览

暂无简介。

•1) Diagnosed with relapse/refractory acute myeloid leukemia (19 years and above to 70 years and below)
•2) Acceptable renal and hepatic function at screening
•- Serum creatinine less than 1.5 times the upper limit of normal
•- Serum Total bilirubin less than 1.5 times the upper limit of normal
•- AST, ALT less than 2 times the upper limit of normal
•3) ECOG performance criteria score of 0 to 2
•4) Subject who have voluntarily given written consent to participate in this study
•5) Subject who received an allo-HSCT(biological parents, siblings, children) or plans to receive one and already has a donor (biological relatives) that plans to donate hematopoietic stem cell

•1) Pregnant and lactating woman, woman who have positive pregnancy test at screening
•2) A female subject of childbearing age that plans a pregnancy during this clinical trial or that has not agreed to use more than one contraceptive methods listed below, or a male subject that has a female partner
•3) Apparent infection or fever(=38?) or bacterial, fungal infection and other serious infectious diseases
•4) History of autoimmune disease that cannot be controlled with low-dose steroid, immunodeficiency or autoimmune disease
•5) high-dose steroids within 28 days of first administration of IP
•6) History of immunotherapy before screening
•7) Malignant tumors or previous history of malignant tumors(<5 years)
•8) Infection of HIV
•9) Severe or uncontrolled severe hypertension exceeding, unstable angina, congestive heart failure(=NYHA class II) or significant internal medical conditions that may interfere with IP (ex. chronic obstructive pulmonary disease, renal failure)
•10) Severe heart disease within 6 months of screening

发起方

ViGenCell