Cytokine-induced Memory-like NK Cells in Patients With Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

Summary

This phase I/2 trial studies the side effects and best dose of activated natural killer cells in treating patients with relapsed or refractory acute myeloid leukemia and myelodysplastic syndromes. Giving chemotherapy before a donor natural killer cell infusion helps stop the growth of cancer cells and stops the patient's immune system from rejecting the donor's natural killer cells. Modified natural killer cells may help the body build an immune response to kill cancer cells. Aldesleukin (interleukin-2) may stimulate the white blood cells (including natural killer cells) to kill leukemia cells.

In the phase II and pediatric portion of the study, the investigators intend to use maximal tolerated or tested (MT/TD) CIML NK cell dose as determined from the phase I part of this study. The phase II portion of the study also replaces IL-2 with ALT-803. The rationale for this change is to support the donor derived NK cells in vivo after adoptive transfer.

With amendment 16, the decision was made to return to the use of rhIL-2 support instead of ALT-803.

Conditions

• Leukemia, Myeloid, Acute

Interventions

DRUG

Fludarabine

DRUG

Cyclophosphamide

PROCEDURE

Leukapheresis

BIOLOGICAL

Cytokine-induced killer cells

BIOLOGICAL

IL-2

DRUG

ALT-803

PROCEDURE

Peripheral blood for correlative studies

-Screening, Day 0 prior to CIML NK infusion, Day 1, Day 3, Day 7, Day 8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 60, Day 100, 6 months, 9 months, 12 months, and at disease relapse

PROCEDURE

Bone marrow for correlative studies

-Screening, Day 8, Day 14, Day 28, Between Day 42 and 60, Day 100, at disease relapse

Sponsors & Collaborators

• American Society of Clinical Oncology

  collaborator OTHER

• American Society of Hematology

  collaborator OTHER

• Gabrielle's Angel Foundation

  collaborator OTHER

• The Leukemia and Lymphoma Society

  collaborator OTHER

• National Cancer Institute (NCI)

  collaborator NIH

• ImmunityBio, Inc.

  collaborator INDUSTRY

• Washington University School of Medicine

  lead OTHER

Principal Investigators

• Amanda Cashen, M.D. · Washington University School of Medicine

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

2 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-08-11

Primary Completion

2021-12-28

Completion

2022-04-04

FDA Drug

Yes

Countries

• United States

Study Locations