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Cytokine Induced Memory-like NK Cell Adoptive Therapy for Relapsed AML After Allogeneic Hematopoietic Cell Transplant

NCT03068819 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2026-04-24

Study results available
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Summary

Donor Lymphocyte Infusion (DLI) following salvage chemotherapy is the one of the most widely used treatment approaches in patients who relapse after allogeneic hematopoietic cell transplant (allo-HCT). However, the complete remission (CR) rates and long term survival remain very poor in these patients and, therefore, there is an unmet need to develop more effective treatment approaches in patients who relapse after allo-HCT.

Based on the initial promising results with our ongoing cytokine-induced memory-like (CIML) natural killer (NK) cell trial, the investigators hypothesize that combining the CIML NK cells with DLI approach will significantly enhance the graft versus leukemia and therefore potentially provide potentially curative therapy for these patients with otherwise extremely poor prognosis. Combining CIML NK cells with the DLI platform will also potentially allow these adoptively transferred cells to persist for longer duration as they should not be rejected by donor T cells as the CIML NK cells are derived from the same donor. The use of CIML NK cells is unlikely to lead to excessive graft versus host disease (GVHD) as previous studies have not been associated with excessive GVHD rates.

Conditions

Interventions

DRUG

CIML NK Cell Infusion

Day 0 and possible second cycle \> 30 days after the first course

PROCEDURE

CD3+ T Cell Product Infusion

Day -1 and possible second cycle \> 30 days after the first course (Pilot Pediatric/Young Adult Cohort). Day 30 and possible second cycle \>30 days after the first course (Phase 2 Adult Cohort)

PROCEDURE

Leukapheresis

On Day -2 or -1

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Wugen, Inc.

    collaborator INDUSTRY

  • Children's Discovery Institute

    collaborator OTHER

  • 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
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-23
Primary Completion
2025-06-15
Completion
2025-06-15
FDA Drug
Yes

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 NCT03068819 on ClinicalTrials.gov