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

ImmunityBio

Status and phase

Completed

Phase 1

Conditions

Acute Myeloid Leukemia

Treatments

Biological: Neukoplast™ (NK-92)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00900809

QUILT-3.018

Details and patient eligibility

About

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.

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.