Clinical Trials /

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

NCT00900809

Description:

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.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: QUILT-3.018
  • NCT ID: NCT00900809

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
Neukoplast™ (NK-92)Neukoplast™ (NK-92)

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.

Trial Arms

NameTypeDescriptionInterventions
Neukoplast™ (NK-92)ExperimentalNeukoplast™ will be infused in three doses.1 x 10e9 cells/m2 dose, 3 x 10e9 cells/m2 dose, 5 x 10e9 cells/m2 dose.
  • Neukoplast™ (NK-92)

Eligibility 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure: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
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Evaluate the therapeutic efficacy of Neukoplast™ in patients with refractory or relapsed acute myeloid leukemia
Time Frame:2016
Safety Issue:
Description:
Measure:Determine the Neukoplast™ cell phenotype and cytotoxic activity at different time intervals after the Neukoplast™ cell infusion
Time Frame:2016
Safety Issue:
Description:
Measure:Determine the presence of Neukoplast™ in the bone marrow
Time Frame:2016
Safety Issue:
Description:
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:NantKwest, Inc.

Trial Keywords

  • Acute Myeloid Leukemia
  • Neukoplast™
  • NK-92
  • Refractory
  • Refractory or Relapsed Acute Myeloid Leukemia

Last Updated