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NCT03300492RecruitingPhase 1/2

Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

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

Source: ClinicalTrials.gov · Last updated 4 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
10 (estimated)
First submitted
30 Jul 2017
Start date
12 Nov 2018
Primary completion date
31 Dec 2026
Lead sponsor
University Hospital, Basel, Switzerland
NCT number
NCT03300492

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 10
  • From 12 Nov 2018 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Presence of relevant (mean fluorescence intensity \>2000) donor-specific anti-HLA antibodies

Other

  • Patient:
  • APL diagnosis
  • Pregnancy
  • Necessity of immunosuppression apart from GvHD prophylaxis
  • Donor:
  • Pregnancy

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Basel
Coordinator of this site? Confirm its status		BaselSwitzerlandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.