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
University Hospital, Basel, Switzerland
10 participants
Nov 12, 2018
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria7
- Patient:
- APL diagnosis
- Presence of relevant (mean fluorescence intensity \>2000) donor-specific anti-HLA antibodies
- Pregnancy
- Necessity of immunosuppression apart from GvHD prophylaxis
- Donor:
- • Pregnancy
Interventions
Application of three infusions of ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses (1x107/kg, 1x108/kg and the remaining cells up to 1x109/kg) following haplo-HSCT. Maximal cumulative T-cell dose is fixed at \<1x105/kg.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT03300492