None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : IP : VT-Tri
Dosage: 15ml (4X10^7 cells)
Administration: Inject intravenously
Cohort 1: single dose, 15ml per dose
Cohort 2: two doses in total, 15ml per dose, we
Sponsors
ViGenCell
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse drug reaction(=Grade 3) related to IP | — |
Secondary
| Measure | Time frame |
|---|---|
| Cardiotoxicity | — |
Countries
Korea, Republic of
Contacts
Public ContactHee-Je Kim
ViGenCell
Outcome results
None listed