Acute Myeloid Leukemia Clinical Trial
Official title:
Clinical Investigation of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified NK92 Cells in Relapsed and/or Refractory Acute Myeloid Leukemias
The purpose of this clinical trial is to study genetically engineered NK92 cell therapy in treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
PRIMARY OBJECTIVES:
Determine the safety and feasibility of the chimeric antigen receptor NK92 cells transduced
with the anti-CD33 vector (referred to as anti-CD33 CAR-NK cells).
SECONDARY OBJECTIVES:
I. For patients with detectable disease, measure anti-leukemia response due to anti-CD33
CAR-NK cell infusions.
II. For patients with stored or accessible leukemia blasts, determine leukemia cell killing
by anti-CD33 CAR-NK in vitro.
III. Determine if cellular or humoral host immunity develops against the murine anti-CD33.
OUTLINE: Patients are assigned to 1 group according to order of enrollment.
Patients receive anti-CD33 CAR-NK (coupled with CD28, CD137 and CD3 zeta signalling domains)
vector-transduced NK92 cell line on days 0,3, and 5 in the absence of disease progression or
unacceptable toxicity.
After completion of study treatment, patients are followed intensively for 6 months, every 3
months for 2 years, and annually thereafter for 10 years.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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