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Clinical Trial 19609

Cancer Type:
Interventions:AMV564

Study Type: Treatment
Phase of Study: Phase I
Investigators:

  • David Sallman

Call 813-745-6100
or 1-800-679-0775
Overview

Study Title

A Phase 1, Multicenter, Open Label Study of AMV564, a Bispecific CD33/CD3 T-cell Engager, in Patients with Intermediate or High-Risk Myelodysplastic Syndromes

Summary

Objective

Primary Objectives: Dose-Escalation Stage To characterize the safety and tolerability of AMV564 To determine the maximum tolerated dose (MTD) of intravenous AMV564 in patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) To identify a dose and schedule for evaluation in the Dose-Expansion Stage Dose-Expansion Stage To further characterize the safety and tolerability of AMV564 in patients with intermediate-2 or high-risk MDS To evaluate preliminary efficacy of AMV564 in patients with intermediate-2 or high-risk MDS

Inclusion Criteria

  • At least 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 ≥ 6 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 > Prior treatment with a therapeutic agent targeting CD33 and/or CD3 (e.g. gemtuzumab ozogamicin, SGN-CD33A or AMG 330).