Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 and up

Using expanded natural killer cells after haploidentical stem cell transplantation for blood cancers

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

Run by University Hospital, Basel, Switzerland · NCT03300492 · Data updated 2026-11-12

This study is testing whether giving special immune cells from a related donor after a stem cell transplant can help people with acute myeloid leukemia or myelodysplastic syndromes fight off cancer and prevent it from coming back.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorUniversity Hospital, Basel, Switzerland
Academic / other
Drugs / interventionscyclophosphamide
Locations1 site (Basel)
StatusRecruiting
StartedNovember 12, 2018
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 4, 2025
Trial IDNCT03300492 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults over 18 years old with AML or MDS who do not have an HLA-matched donor and are eligible for haplo-HSCT.

Probably not a fit

Patients with acute promyelocytic leukemia (APL) or those requiring significant immunosuppression may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the use of expanded natural killer (NK) cells following haploidentical hematopoietic stem cell transplantation (haplo-HSCT) for patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS). The approach aims to enhance the immune response against tumor cells by administering NK cells derived from the patient's haploidentical donor after transplantation. The primary focus is to assess the safety and feasibility of this method, as well as the activity of the NK cells in combating relapse of AML/MDS. Participants will be monitored for their response and any potential side effects associated with the treatment.

Why it matters

Potential benefit: If successful, this approach could improve outcomes for patients with AML or MDS by reducing the risk of cancer relapse after transplantation.

How similar studies have gone: While the use of NK cells in this context is promising, the specific combination of expanded NK cells following haplo-HSCT is a novel approach that has not been extensively tested in prior studies.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • University Hospital Basel
    Basel, Switzerland
    Recruiting

Study contacts

  • Principal investigator: Jakob Passweg, Prof. MD — University Hospital Basel, Basel Switzerland
  • Study coordinator: Matyas Ecsedi, MD-PhD
  • Email: matyas.ecsedi@usb.ch
  • Phone: +41612652525

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.