QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia
NK cells from patients with malignant diseases are often functionally impaired. Their function cannot be fully restored through ex vivo expansion and cytokine activation. In addition, the in vivo administration of cytokines not only expands NK cells but expands polyclonal T cells with no tumor specificity and no known effects.
The utilization of Neukoplast™, as a form of adoptive immunotherapy, offers several advantages. Neukoplast™ represents a uniform cell population with a well-characterized immunophenotype, confirmed strong anti-tumor activity and are easy to grow and expand in culture, so that they can be made available in large numbers for therapeutic delivery.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I Study of Adoptive Immunotherapy Using the Natural Killer Cell Line, Neukoplast™(NK-92), for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia|
- Determine the safety / maximum tolerated dose of Neukoplast™ (NK-92 cell line for clinical use) in patients with refractory or relapsed acute myeloid leukemia [ Time Frame: 2016 ] [ Designated as safety issue: Yes ]
- Evaluate the therapeutic efficacy of Neukoplast™ in patients with refractory or relapsed acute myeloid leukemia [ Time Frame: 2016 ] [ Designated as safety issue: Yes ]
- Determine the Neukoplast™ cell phenotype and cytotoxic activity at different time intervals after the Neukoplast™ cell infusion [ Time Frame: 2016 ] [ Designated as safety issue: No ]
- Determine the presence of Neukoplast™ in the bone marrow [ Time Frame: 2016 ] [ Designated as safety issue: No ]
- Determine the effects of Neukoplast™ on the host immune system, using flow cytometry and the LUMINEX multianalytic profiling system, at different time intervals after the Neukoplast™ infusion. [ Time Frame: 2016 ] [ Designated as safety issue: No ]
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Neukoplast™ (NK-92)
Neukoplast™ will be infused in three doses.1 x 10e9 cells/m2 dose, 3 x 10e9 cells/m2 dose, 5 x 10e9 cells/m2 dose.
Biological: Neukoplast™ (NK-92)
The Neukoplast™ (NK-92) cells will be administered intravenously over 60 minutes. The starting dose of Neukoplast™ (NK-92) cells will be 1 x 10e9 ZRx-101 cells/m2 (The 3 dose levels are: 1 x 10e9 cells/m2, 3 x 10e9 cells/m2 and 5 x 10e9 cells/m2). The second infusion will only be administered after 24 hours if no unacceptable or dose limiting toxicities side effects due to the infusion of Neukoplast™ were encountered after the first infusion.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00900809
|United States, Pennsylvania|
|UPMC Cancer Center - Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Michael Boyiadzis, MD||University of Pittsburgh|