Allogeneic Engineered Hematopoietic Stem Cell Transplant (HCT) Lacking the CD33 Protein, and Post-HCT Treatment With Mylotarg, for Patients With CD33+ AML
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What's the purpose of this trial?

This is a Phase 1/2a, multicenter, open-label, first-in-human (FIH) study of VOR33 in participants with AML who are undergoing human leukocyte antigen (HLA)-matched allogeneic hematopoietic cell transplant (HCT).

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

Inclusion Criteria:

  • Must be ≥18 and ≤70 years of age.
  • Must have confirmed diagnosis of AML in first or second complete remission (CR1 or CR2) or have bone marrow blasts ≤10% without circulating blasts.
  • AML sample from the patient must have evidence of CD33 expression (>0%)
  • AML must have intermediate or high-risk disease-related genetics and the presence of minimal residual disease (MRD). Subjects in CR2 or with persistent morphologic blasts; may have favorable disease-related genetics.
  • Candidate for HLA-matched allogeneic HCT using a myeloablative conditioning regimen.
  • Must have a related or unrelated stem cell donor that is a 10/10 match for HLA-A, -B, -C, -DRB1 and -DQB1.
  • Must have adequate performance status and organ function as defined below:
    • Performance Status: Karnofsky score of ≥70.
    • Cardiac: left ventricular ejection fraction (LVEF) ≥50%
    • Pulmonary: diffusing capacity of lung for carbon monoxide (DLCO), forced vital capacity (FVC), and forced expiratory volume in one second (FEV1) ≥66%.
    • Renal: estimated glomerular filtration rate (GFR) >60 mL/min
    • Hepatic: total bilirubin <1.5 × ULN, or if ≥1.5 × ULN direct bilirubin <ULN and ALT/AST <1.5 × ULN (per institutional criteria).

Exclusion Criteria:

  • Prior autologous or allogeneic stem cell transplantation.
  • Presence of the following disease-related genetics: t(15; 17)(q22; q21), or t(9; 22)(q34; q11), or other evidence of acute promyelocytic leukemia or chronic myeloid leukemia.
  • Prior treatment with Mylotarg™ (gemtuzumab ozogamicin).
  • Active central nervous system (CNS) leukemia or history of other active malignancy(ies).
  • Patients diagnosed with Gilbert's syndrome.
  • Uncontrolled bacterial, viral, or fungal infections; or known human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C infection.

Additional Trial Information

Phase 1/2

Enrollment: 18 patients (estimated)

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(888) 828-2206

Trial Locations

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New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting
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