A Dose Escalation Study of NK-92 Cell Infusions in Patients With Hematological Malignancies in Relapse After Autologous Stem Cell Transplantation.
Patients with hematological malignancies such as acute leukemia, lymphoma, Hodgkin's disease
and myeloma, are generally treated initially with chemotherapy, radiotherapy or a
combination of both. High dose therapy and autotransplantation are often utilized in the
management of such patients, either as part of initial therapy or for treatment of relapsed
disease. When a patient's cancer relapses after transplantation, the prognosis is dismal.
Therapeutic options are usually limited to palliative chemotherapy and/or local radiation,
and for persons with excellent performance status experimental treatments are considered on
an ad hoc basis.
Much interest in the last decade has focused on the role of cellular and immunotherapy in
this setting. Cancer vaccines and the administration of adoptive cellular and immunotherapy
have the theoretical advantage of being non cross-reactive with previous treatments (such as
radiotherapy and chemotherapy) and are currently under investigation using a variety of
methodologies. NK cells comprise roughly 15% of all lymphocytes in the peripheral blood.
They normally function as part of the innate immune system, which provides the body's
initial response to infection and malignancy. However, patients with malignancies frequently
have impaired NK cell function, as evidenced by reduced in vitro proliferative responses and
reduced cytotoxic activity. The infusion of an irradiated NK cell line is appealing as it is
a source of cells that can be expanded to therapeutic quantities, and retains anti-tumor
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine if there are any dose limiting toxicities to this therapy, as well as the maximum tolerated dose.
Day 1, 3, and 5 of each cycle
Armand Keating, MD
Princess Margaret Hospital, Canada
Canada: Health Canada