QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00900809|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2009
Last Update Posted : March 29, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Biological: Neukoplast™ (NK-92)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||May 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
- 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 ]
- Evaluate the therapeutic efficacy of Neukoplast™ in patients with refractory or relapsed acute myeloid leukemia [ Time Frame: 2016 ]
- Determine the Neukoplast™ cell phenotype and cytotoxic activity at different time intervals after the Neukoplast™ cell infusion [ Time Frame: 2016 ]
- Determine the presence of Neukoplast™ in the bone marrow [ Time Frame: 2016 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00900809
|United States, Pennsylvania|
|UPMC Cancer Center - Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||Michael Boyiadzis, MD||University of Pittsburgh|