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)

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0007025
• Lead Sponsor: ViGenCell

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 8 March 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 9

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

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

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse drug reaction(=Grade 3) related to IP

Secondary Outcome Measures

Name	Time	Method
Cardiotoxicity