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Taking people in SwitzerlandPhase 1/2

Donor natural killer cells after stem cell transplant for leukemia or myelodysplastic syndromes

Tests donor-derived natural killer cells after transplant in adults with leukemia or myelodysplastic syndromes.

Key facts

Who runs it
University Hospital, Basel, Switzerland
Where
Basel, SwitzerlandSee the site
Trial code
Registry title
Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS
Status
Recruiting
Phase
Phase 1/2
People taking part
10 people, planned
Started
12 Nov 2018
Expected to end
31 Dec 2026
Type of study
Interventional
Treatments tested
  • NK-DLI
Record updated
4 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with acute myeloid leukemia (AML) or a type of myelodysplastic syndrome (MDS-EB) who need a stem cell transplant from a half-matched family donor and have no fully matched donor.

Age
Over 18 years for patients and for donors.
Sex
All sexes can join.
Disease stage
AML or MDS-EB with a reason for a haploidentical stem cell transplant (haplo-HSCT) under the University Hospital Basel Stem Cell Transplant Team guidelines.
Earlier treatment
No HLA-matched related or unrelated donor is available. A half-matched (haploidentical) related donor is available. The transplant physicians judge that organ function is adequate and nothing speaks against the transplant.

Main reasons for not taking part

  • APL diagnosis
  • Relevant donor-specific anti-HLA antibodies (mean fluorescence intensity >2000)
  • Pregnancy (patient or donor)
  • Need for immunosuppression apart from GvHD prophylaxis

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

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

Where in Switzerland

  • University Hospital BaselBasel, SwitzerlandContact: Matyas Ecsedi, MD-PhDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • NK-DLITreatment being tested

    Preemptive immunotherapy with ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses following haplo-HSCT.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase I/II Single Center Study to Assess the Safety, Tolerability and Feasibility of Pre-emptive Immunotherapy With in Vitro Expanded Natural Killer Cells in Patients Treated With Haplo-HSCT for AML/MDS
Plain-language title
Donor natural killer cells after stem cell transplant for leukemia or myelodysplastic syndromesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
4 December 2025