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Lead
Amphivena Therapeutics, Inc.
A dose-escalation with expansion study of AMV564 (T cell engager) as monotherapy in patients with intermediate-2 or high-risk Myelodysplastic Syndromes
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
≥ 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.
You may not be if
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).
Clareo Health | A Phase 1 Study of AMV564 in Patients With Intermediate or High-Risk Myelodysplastic Syndromes
