Lymphodepleting Chemotherapy and T-Cell Suppression Followed By Allogeneic Natural Killer Cells and IL-2 in Patients With Recurrent Ovarian, Fallopian Tube, Primary Peritoneal Cancer and Advanced Metastatic Breast Cancer (MT2009-30)
The donor NK cells are infused on day 0, after a non-myeloablative preparative regimen of
cyclophosphamide and fludarabine plus a cyclosporine A (CsA) based immunosuppressive
therapy. Subcutaneous interleukin-2 (IL-2) is started the evening of the NK infusion and
continued three times a week for 6 doses total.
Up to 4 sequential immunosuppressive platforms will be tested (Arms 1 and 2 are currently
closed) to identify a platform where patients have the potential for successful NK cell
expansion (defined as an absolute circulating donor derived NK cell count of > 100 cells/μl
14 days after NK cell infusion). Once a clinical platform is determined, the platform will
be expanded to a total of 18 patients. The primary goal of this extended phase is to obtain
preliminary efficacy information.
Follow-up for disease response is for 1 year from the NK cell infusion, with the possibility
of re-treatment for patients who experience at least a clinical benefit who progress after 6
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Disease response demonstrated by using standard response criteria (RECIST) (Stable Disease (SD) + Partial Response (PR) + Complete Response (CR) after haploidentical donor NK cell infusion in patients with recurrent ovarian or breast cancer.
Sarah Cooley, MD
Masonic Cancer Center, University of Minnesota
United States: Food and Drug Administration
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