Phase 1/2a, Single Dose Study Investigating NTLA-5001 in Subjects with Acute Myeloid Leukemia

This study will be conducted to evaluate the safety, tolerability, cellular kinetics (CK),
activity, and pharmacodynamics (PD) of NTLA-5001 in participants with Acute Myeloid Leukemia
(AML).

Inclusion Criteria (abbreviated):

- 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

Exclusion Criteria (abbreviated):

- 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.