NCT03669172

Efectiveness of Donor IL-15-stimulated NK Cells Post Transplant Infusion in in Acute Leukemia

Completed Phase 1, PHASE2 Last updated 5 September 2021

What this trial tests

Phase 1, PHASE2 trial testing Donor IL-15 stimulated NK cells infusion in ACUTE LEUKEMIA in 6 participants. Completed in 6 July 2021.

Timeline

2 November 2017

Primary endpoint
6 July 2021

6 July 2021

Quick facts

Lead sponsor	Martín, José Luis Díez, M.D.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	2 November 2017
Primary completion	6 July 2021
Estimated completion	6 July 2021
Sites	1 location across Spain

Drugs / interventions tested

• Donor IL-15 stimulated NK cells infusion — full drug profile →

Conditions studied

• ACUTE LEUKEMIA — all drugs for ACUTE LEUKEMIA →

Sponsor

Martín, José Luis Díez, M.D. — full company profile →

Who can join

Adults 18 to 100, any sex, with ACUTE LEUKEMIA. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Clinical trial phase I and II, single-center, historical control, to evaluate the effectiveness of donor IL-15 stimulated NK cells post transplant infusion, in acute leukemia patients with poor prognosis and haploidentical unmanipulated transplant

Publications & conference data

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

1. Immunomodulatory Effects of IL-2 and IL-15; Implications for Cancer Immunotherapy.
   Yang Y, Lundqvist A. · · 2020 · cited 149× · PMID 33266177 · DOI 10.3390/cancers12123586
2. The use of supercytokines, immunocytokines, engager cytokines, and other synthetic cytokines in immunotherapy.
   Zheng X, Wu Y, Bi J, Huang Y, et al · · 2022 · cited 112× · PMID 35043005 · DOI 10.1038/s41423-021-00786-6
3. NK Cell-Based Immunotherapies in Cancer.
   Shin MH, Kim J, Lim SA, Kim J, et al · · 2020 · cited 103× · PMID 32395366 · DOI 10.4110/in.2020.20.e14
4. Inflammation in cancer: therapeutic opportunities from new insights.
   Xie Y, Liu F, Wu Y, Zhu Y, et al · · 2025 · cited 53× · PMID 39994787 · DOI 10.1186/s12943-025-02243-8
5. Understanding NK cell biology for harnessing NK cell therapies: targeting cancer and beyond.
   Shin E, Bak SH, Park T, Kim JW, et al · · 2023 · cited 46× · PMID 37539051 · DOI 10.3389/fimmu.2023.1192907
6. NK Cell Adoptive Immunotherapy of Cancer: Evaluating Recognition Strategies and Overcoming Limitations.
   Sanchez CE, Dowlati EP, Geiger AE, Chaudhry K, et al · · 2021 · cited 21× · PMID 33007496 · DOI 10.1016/j.bbmt.2020.09.030
7. Novel agents targeting leukemia cells and immune microenvironment for prevention and treatment of relapse of acute myeloid leukemia after allogeneic hematopoietic stem cell transplantation.
   Shi W, Jin W, Xia L, Hu Y. · · 2020 · cited 15× · PMID 32837873 · DOI 10.1016/j.apsb.2020.06.012
8. The 45th Annual Meeting of the European Society for Blood and Marrow Transplantation: Physicians - Poster Session.
   · 2019 · cited 7× · PMID 31270396 · DOI 10.1038/s41409-019-0559-4