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

NCT00900809 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-04-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • ImmunityBio, Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Boyiadzis, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-12
Primary Completion
2015-06-02
Completion
2015-06-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00900809 on ClinicalTrials.gov