NCT00900809

QUILT-3.018: Neukoplast™ (NK-92) for the Treatment of Refractory or Relapsed Acute Myeloid Leukemia

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: ImmunityBio, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Acute Myeloid Leukemia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-05-12
• Primary completion: 2015-06-02
• Completion: 2015-06-02
• First posted: 2009-05-13
• Last updated: 2022-04-05

Locations

1 site across 1 country: United States