NCT03068819

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

Completed Phase 1, PHASE2 Last updated 14 October 2025

What this trial tests

Phase 1, PHASE2 trial testing CIML NK Cell Infusion in Acute Myeloid Leukemia in 62 participants. Completed in 15 June 2025.

Timeline

23 October 2017

Primary endpoint
15 June 2025

15 June 2025

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	62
Start date	23 October 2017
Primary completion	15 June 2025
Estimated completion	15 June 2025
Sites	1 location across United States

Drugs / interventions tested

• CIML NK Cell Infusion — full drug profile →
• CD3+ T Cell Product Infusion

Conditions studied

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

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Acute Myeloid Leukemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

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

1. Exploring the NK cell platform for cancer immunotherapy.
   Myers JA, Miller JS. · · 2021 · cited 977× · PMID 32934330 · DOI 10.1038/s41571-020-0426-7
2. Cytokines in the Treatment of Cancer.
   Conlon KC, Miljkovic MD, Waldmann TA. · · 2019 · cited 360× · PMID 29889594 · DOI 10.1089/jir.2018.0019
3. Allogeneic natural killer cell therapy.
   Berrien-Elliott MM, Jacobs MT, Fehniger TA. · · 2023 · cited 153× · PMID 36416736 · DOI 10.1182/blood.2022016200
4. Natural Killer Cells as Allogeneic Effectors in Adoptive Cancer Immunotherapy.
   Lupo KB, Matosevic S. · · 2019 · cited 146× · PMID 31163679 · DOI 10.3390/cancers11060769
5. Natural killer cells: a promising immunotherapy for cancer.
   Chu J, Gao F, Yan M, Zhao S, et al · · 2022 · cited 140× · PMID 35606854 · DOI 10.1186/s12967-022-03437-0
6. Donor memory-like NK cells persist and induce remissions in pediatric patients with relapsed AML after transplant.
   Bednarski JJ, Zimmerman C, Berrien-Elliott MM, Foltz JA, et al · · 2022 · cited 123× · PMID 34871371 · DOI 10.1182/blood.2021013972
7. Multidimensional Analyses of Donor Memory-Like NK Cells Reveal New Associations with Response after Adoptive Immunotherapy for Leukemia.
   Berrien-Elliott MM, Cashen AF, Cubitt CC, Neal CC, et al · · 2020 · cited 121× · PMID 32826231 · DOI 10.1158/2159-8290.cd-20-0312
8. Targeting Natural Killer Cells for Tumor Immunotherapy.
   Zhang C, Hu Y, Shi C. · · 2020 · cited 91× · PMID 32140153 · DOI 10.3389/fimmu.2020.00060