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Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Recruiting
18 years and older
All
Phase 1/2

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Overview

The study examines the application of expanded natural killer cells (NK cells) following haploidentical allogeneic hematopoietic stem cell transplantation (haplo-HSCT) for AML or MDS. Haplo-HSCT is a preferred treatment option for patients with AML or MDS without a HLA-matched donor. With administration of cyclophosphamide post-transplant , the safety of the procedure is similar to a HSCT from a HLA-identical donor. Relapse of AML/MDS represents a serious problem following haplo-HSCT. NK cells are immune cells able to destroy tumor cells. Their potency has been established particularly in the setting of a haplo-HSCT. In the current study, study participants undergoing haplo-HSCT will receive expanded NK cells from their respective stem-cell donors following haplo-HSCT. The primary goal of the study is to establish the safety and feasibility of this approach. In addition, the activity of the NK cells will be examined.

Eligibility

Inclusion Criteria:

Patient
  • >18 years of age
  • No HLA-matched related or unrelated donor available
  • AML or MDS-EB with indication for a haplo-HSCT according to the guidelines of the University Hospital Basel Stem Cell Transplant Team
  • Judged by the transplant physicians to have adequate organ function and no contraindications to haplo-HSCT
  • Available related haploidentical donor
  • Written informed consent
Donor
  • >18 years old, haploidentical parent, sibling or other relative
  • Donor suitable for cell donation and apheresis according to standard criteria
  • Written informed consent

Exclusion Criteria:

Patient
  • APL diagnosis
  • Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA antibodies
  • Pregnancy
  • Necessity of immunosuppression apart from GvHD prophylaxis

Exclusion Criteria:

Donor

• Pregnancy

Study details
    Acute Myeloid Leukemia
    Myelodysplastic Syndromes

NCT03300492

University Hospital, Basel, Switzerland

14 October 2025

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