Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

Recruiting now · Phase 1/Phase 2

Conditions studied: Acute Myeloid Leukemia, Myelodysplastic Syndromes

In brief

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.

Key facts

Study ID

NCT03300492

Run by

University Hospital, Basel, Switzerland

People needed

10

Starts

2018-11-12

Expected to finish

2026-12-31

Last updated by the study team

2025-12-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University Hospital Basel — Basel, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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