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

Who is this study for? Patients treated with haplo-HSCT for AML/MDS
What treatments are being studied? NK-DLI
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
Switzerland
University Hospital Basel
RECRUITING
Basel
Contact Information
Primary
Matyas Ecsedi, MD-PhD
matyas.ecsedi@usb.ch
+41612652525
Time Frame
Start Date: 2018-11-12
Estimated Completion Date: 2026-01-31
Participants
Target number of participants: 10
Treatments
Experimental: NK-DLI
Preemptive immunotherapy with ex vivo expanded NK cells on days~+10, +15 and +20 with increasing NK cell doses following haplo-HSCT.
Sponsors
Leads: University Hospital, Basel, Switzerland

This content was sourced from clinicaltrials.gov

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