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Clinical Trial 19609

Cancer Type: Malignant Hematology

Study Type: Treatment
Phase of Study: Phase I

  • David Sallman

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

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



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 ≥ 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 > Prior treatment with a therapeutic agent targeting CD33(e.g. gemtuzumab ozogamicin, SGN-CD33A or AMG 330).
  • Treatment with anti-thymocyte globulin (ATG) within 28 days prior to start date of AMV564.
  • Treatment with any local or systemic anti-neoplastic therapy or radiation within 14 days prior to the initiation of AMV564 administration (hydroxyurea is exempted if used to reduce total WBC counts)
  • Clinically significant cardiac disease
  • Evidence of active, uncontrolled, viral, bacterial, or systemic fungal infection. Prophylactic therapy according to institutional protocols is acceptable.
  • Known positive test result for human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)
  • Active hepatitis C virus (HCV) or hepatitis B virus (HBV). Patients who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative polymerase chain reaction (PCR) result before enrollment. Those who are PCR positive will be excluded.
  • Second primary malignancy that has not been in remission for greater than 1 year. Exceptions apply.
  • Major trauma or major surgery within 28 days prior to the initiation of AMV564 treatment
  • Any serious underlying medical or psychiatric condition or other issue that would limit compliance with study requirements, impair the ability of the patient to understand informed consent, or that in the opinion of the investigator would contraindicate the patient¿s participation in the study or confound the results of the study.
  • Known hypersensitivity, allergies, or intolerance to immunoglobulins, human serum albumin or to any excipient contained in AMV564.
  • Ability to become pregnant. However, female patients who have a negative serum or urine pregnancy test before enrollment and agree to use two highly effective forms of contraception during the trial and for 30 days afterward (30 days after the end of AMV564 treatment) are considered eligible.
  • Male patients with partners of childbearing potential (unless they agree to take measures not to father children by using one form of highly effective contraception [condom plus spermicide] during the trial and for 90 days after the end of AMV564 treatment). Men with pregnant or lactating partners should be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure to the fetus or neonate.
  • Pregnant or breastfeeding women.
  • Is a participant or plans to participate in another interventional clinical study, while taking part in this protocol. Participation in an observational study is acceptable.