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Trial Testing Safety of IL-21 NK Cells for Induction of R/R AML

NCT04220684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2026-01-09

No results posted yet for this study

Summary

This phase I trial studies the side effects of donor natural killer (NK) cell therapy in treating patients with acute myeloid leukemia that has come back (recurrent) or has not responded to treatment (refractory). Natural killer cells are a type of immune cell. Immunotherapy with genetically modified NK cells from donors may induce changes in the body's immune system and may interfere with the ability of cancer cells to grow and spread.

Conditions

  • Allogeneic Stem Cell Transplant Recipient
  • Blasts 10 Percent or More of Bone Marrow Nucleated Cells
  • Recurrent Acute Myeloid Leukemia
  • Refractory Acute Myeloid Leukemia

Interventions

DRUG

Cytarabine Hydrochloride

Given IV

DRUG

Fludarabine

Given IV

BIOLOGICAL

Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells

Given via infusion

Sponsors & Collaborators

  • Kiadis Pharma

    collaborator INDUSTRY

  • Sumithira Vasu

    lead OTHER

Principal Investigators

  • Sumithira Vasu, MBBS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-11
Primary Completion
2024-10-22
Completion
2024-10-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT04220684 on ClinicalTrials.gov