Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NK-DLI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK-DLI
- description
- Preemptive immunotherapy with ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses following haplo-HSCT.
- interventionNames
- Other: NK-DLI
Primary outcomes (1)
- measure
- Incidence and severity of adverse events including GvHD and infections.
- timeFrame
- 1 year following haplo HSCT
- description
- As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.
Secondary outcomes (5)
- measure
- Progression-free survival (PFS)
- timeFrame
- 1 year following haplo HSCT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available