A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes

A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients
with intermediate-2 or high-risk Myelodysplastic Syndromes

Inclusion Criteria:

- ≥ 18 years of age

- Diagnosis of MDS according to WHO 2016 criteria

- ECOG performance status of 0 or 1

- Intermediate-2 or high-risk disease per IPSS

- Fewer than 20% blasts in the bone marrow or peripheral blood

- Disease that is refractory to or relapsed from either a hypomethylating agent (e.g.
decitabine or azacitidine) or a standard AML-type intensive regimen

- Adequate organ function

- Prior allogeneic transplant performed ≥ 3 months prior to first dose of AMV564 is
allowed provided there is no evidence of active graft-versus-host disease (GVHD) and
the patient has been off immunosuppressive therapy for ≥ 4 weeks.

Exclusion Criteria:

- History of, or known, central nervous system (CNS) disease involvement, or prior
history of National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events
(CTCAE) Grade ≥ 3 drug-related CNS toxicity

- Prior allogeneic transplant if performed < 3 months prior to first dose of AMV564, if
patient has active GVHD, or if patient has not been off immunosuppressive

- Prior treatment with a therapeutic agent targeting CD33 (e.g. gemtuzumab ozogamicin,
SGN-CD33A or AMG 330).