Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Intellia Therapeutics
This 2-part first in human (FIH) study is comprised of two open-label arms. It is a multi-center, Phase 1/2a study evaluating the safety and activity of NTLA-5001 in subjects with persistent or recurrent Acute Myeloid Leukemia after first-line or later therapy.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Has AML as defined by World Health Organization
Has detectable disease following first-line therapy
Is ≥ 18 years of age.
Carries the human leukocyte antigen-A0201 (HLA-A\*02:01) allele.
Has ECOG performance status of 0 to 1.
Has adequate absolute total lymphocyte count
Has adequate cardiac, renal, and liver organ function
You may not be if
Has received AML-directed therapy or immunomodulatory therapy within a specified window prior to study entry.
Has received allogeneic hematopoietic cell transplant within 84 days, with ongoing GVHD, with recent DLI, or on active immunosuppression.
Has CNS involvement by tumor.
Has severe autoimmunity requiring immunomodulatory therapy.
Has active disseminated intravascular coagulation (DIC), bleeding or coagulopathy.
Has leukocytosis ≥ 20,000 blasts/μL despite hydroxyurea or has rapidly progressive disease
Has human immunodeficiency virus (HIV) infection, or any uncontrolled infection.
Female subjects are pregnant or breastfeeding; or are of childbearing potential and are unwilling to use protocol specified method of contraception.
Male subjects who have female partners of childbearing potential and are unwilling to use protocol specified method of contraception.
