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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Conkwest, Incorporated
Sponsor:
Information provided by (Responsible Party):
Conkwest, Incorporated
ClinicalTrials.gov Identifier:
NCT00900809
First received: May 11, 2009
Last updated: June 25, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
Biological: Neukoplast™ (NK-92)
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Conkwest, Incorporated:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 18
Study Start Date: May 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with refractory/relapse acute myeloid leukemia. Patients must not have received radiotherapy, chemotherapy (with the exception of hydroxyurea which must be discontinued 72 hours prior to therapy) or biological therapy within the preceding 2 weeks of the planned first Neukoplast™ cell infusion and must have recovered from any adverse events due to prior administered agents
  • Assessable disease as measured by laboratory and bone marrow examinations
  • Age: Eighteen years or older
  • Performance status: ECOG ≤ 2 (Appendix A)
  • Serum creatinine < 2 X upper limit of normal
  • Aspartate aminotransferase (AST) < 5 X upper limit of normal
  • Alanine aminotransferase (ALT) < 5 X upper limit of normal
  • Total bilirubin < 3X upper limit of normal
  • Activated partial thromboplastin time (PTT) < 2.5 X upper limit of normal
  • Patients must have left ventricular ejection fraction (LVEF) ≥45 %
  • Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of Neukoplast™
  • Ability to give informed consent
  • Life expectancy of greater than 3 months

Note: as many of eligible patients will be pancytopenic secondary to their disease or prior therapies hematologic abnormalities will not be used as a criteria for entry or exclusion.

Exclusion Criteria:

  • Patients with acute promyelocytic leukemia
  • Symptomatic central nervous system (CNS) involvement
  • History of congestive heart failure
  • Evidence of severe or uncontrolled systemic diseases (e.g., unstable or uncompensated respiratory, hepatic, renal, or cardiac disease).
  • Uncontrolled, life-threatening infection that is not responding to antimicrobial therapy
  • ECOG performance status >2 (Appendix A)
  • Hepatitis B or C or HIV positive serology
  • History of psychiatric disorder which may compromise compliance with the protocol or which does not allow for appropriate informed consent
  • Patient may not be receiving any other investigational agents
  • Patient is receiving systemic anticoagulation (e.g., warfarin, intravenous heparin. Low dose prophylactic anticoagulation is allowed )
  • Patient undergone autologous or allogeneic stem cell transplantation
  • Concurrent malignancy of solid tumors. Exception: Subjects who have been disease-free for 5 years, or subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinoma are eligible. Subjects with second malignancies that are indolent or definitively treated may be enrolled.
  • Pregnant or lactating female.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00900809

Contacts
Contact: Karen M. Nichols, Esq. 617-982-2462 ext 202 knichols@conkwest.com
Contact: Hans Klingemann, MD, PhD 617-982-2461 ext 201 hklingemann@conkwest.com

Locations
United States, Pennsylvania
UPMC Cancer Center - Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
Conkwest, Incorporated
Investigators
Principal Investigator: Michael Boyiadzis, MD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Conkwest, Incorporated
ClinicalTrials.gov Identifier: NCT00900809     History of Changes
Other Study ID Numbers: UPCI 12-151
Study First Received: May 11, 2009
Last Updated: June 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Conkwest, Incorporated:
Acute Myeloid Leukemia
Neukoplast™
NK-92
Refractory
Refractory or Relapsed Acute Myeloid Leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 27, 2014