NCT04354025

Cytokine-induced Memory-like NK Cells in Combination With Chemotherapy in Pediatric Patents With Refractory or Relapsed AML

Withdrawn Phase 2 Last updated 4 April 2023

What this trial tests

Phase 2 trial testing Cytokine induced memory-like NK cells in Refractory Acute Myeloid Leukemia. Withdrawn.

Timeline

30 June 2023

Primary endpoint
30 September 2026

31 July 2028

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	30 June 2023
Primary completion	30 September 2026
Estimated completion	31 July 2028

Drugs / interventions tested

• Cytokine induced memory-like NK cells — full drug profile →
• Fludarabine (FLUDARABINE) — full drug profile →
• Ara-C — full drug profile →
• G-CSF (g-csf) — full drug profile →
• Interleukin-2
• Leukapheresis — full drug profile →

Conditions studied

• Refractory Acute Myeloid Leukemia — all drugs for Refractory Acute Myeloid Leukemia →
• Relapsed Acute Myeloid Leukemia — all drugs for Relapsed Acute Myeloid Leukemia →

Sponsor

Washington University School of Medicine

Who can join

Adults 1 to 21, any sex, with Refractory Acute Myeloid Leukemia or Relapsed Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase 2 clinical trial investigates the effectiveness of cytokine-induced memory-like natural killer (CIML NK) cells in combination with FLAG chemotherapy as a treatment for refractory or relapsed AML. Previous studies in adults with AML sowed successful induction of remission and a previous phase 1 study demonstrated that CIML NK cells can be used safely in pediatric patients. This phase 2 study uses FLAG chemotherapy to lower leukemic burden and suppress the recipient's immune system to provide an optimal environment for CIML NK cell expansion and anti-leukemic activity.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Natural killer cells in clinical development as non-engineered, engineered, and combination therapies.
   Lamers-Kok N, Panella D, Georgoudaki AM, Liu H, et al · · 2022 · cited 125× · PMID 36348457 · DOI 10.1186/s13045-022-01382-5
2. Cytokine-Induced Memory-Like NK Cells: From the Basics to Clinical Applications.
   Terrén I, Orrantia A, Astarloa-Pando G, Amarilla-Irusta A, et al · · 2022 · cited 84× · PMID 35603208 · DOI 10.3389/fimmu.2022.884648
3. Natural killer cell-based immunotherapy for acute myeloid leukemia.
   Xu J, Niu T. · · 2020 · cited 83× · PMID 33287858 · DOI 10.1186/s13045-020-00996-x
4. Metabolic changes of Interleukin-12/15/18-stimulated human NK cells.
   Terrén I, Orrantia A, Mosteiro A, Vitallé J, et al · · 2021 · cited 67× · PMID 33742092 · DOI 10.1038/s41598-021-85960-6
5. Immunotherapy with NK cells: recent developments in gene modification open up new avenues.
   Reindl LM, Albinger N, Bexte T, Müller S, et al · · 2020 · cited 36× · PMID 33457093 · DOI 10.1080/2162402x.2020.1777651
6. Targeting the innate immune system in pediatric and adult AML.
   Perzolli A, Koedijk JB, Zwaan CM, Heidenreich O. · · 2024 · cited 32× · PMID 38459166 · DOI 10.1038/s41375-024-02217-7
7. Optimizing NK Cell-Based Immunotherapy in Myeloid Leukemia: Abrogating an Immunosuppressive Microenvironment.
   Kaweme NM, Zhou F. · · 2021 · cited 21× · PMID 34220833 · DOI 10.3389/fimmu.2021.683381
8. Natural killer cells and acute myeloid leukemia: promises and challenges.
   Rahmani S, Yazdanpanah N, Rezaei N. · · 2022 · cited 20× · PMID 35639116 · DOI 10.1007/s00262-022-03217-1