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
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Basel) |
| Status | Recruiting |
| Started | November 12, 2018 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 4, 2025 |
| Trial ID | NCT03300492 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.
-
FXS0683 in relapsed or refractory blood cancers
This first‑in‑human study tests FXS0683 in adults with relapsed or refractory B‑cell lymphoma, AML, MDS, or ALL to see if it is safe, how the drug behaves in the body, and whether it shows any antitumor activity.
-
Reduced-intensity donor stem cell transplant with treosulfan/fludarabine and post-transplant cyclophosphamide for leukemia and MDS
This trial tests a lower-intensity donor stem cell transplant using treosulfan plus fludarabine with post-transplant cyclophosphamide to try to reduce toxicity and prevent graft-versus-host disease in people aged 2–75 with acute leukemias or myelodysplastic syndromes.
-
CD33-armed immune cell treatment for adults with MRD-positive AML or MDS
This treatment will try giving adults with MRD-positive AML or MDS infusions of their own T cells coated with a CD33-directed bispecific antibody together with standard hypomethylating therapy (and possibly venetoclax) to see if it is safe and lowers residual disease.
-
Venetoclax-enhanced BUCY versus standard BUCY conditioning for high‑risk AML and MDS before allogeneic stem cell transplant
This will test whether adding venetoclax to BUCY conditioning before allogeneic stem cell transplant helps patients aged 12–60 with high‑risk AML or MDS stay in remission longer.
-
Blood transfusions at home
This pilot tests whether giving required blood transfusions at home works well and is acceptable for adults with transfusion-dependent blood cancers or bone marrow failure who receive care at SKCCC.
-
Adding decitabine and venetoclax to fludarabine/melphalan reduced‑intensity transplant for myeloid cancers
This study tests whether giving decitabine and venetoclax around a reduced‑intensity allogeneic transplant is safe for adults with high‑risk acute myeloid leukemia or myelodysplastic syndromes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.