Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS

NCT ID: NCT03300492

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2026-12-31

Brief 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.

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NK-DLI

Preemptive immunotherapy with ex vivo expanded NK cells on days

+10, +15 and +20 with increasing NK cell doses following haplo-HSCT.

Group Type: EXPERIMENTAL

NK-DLI

Intervention Type: OTHER

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.

Interventions

NK-DLI

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.

Intervention Type: OTHER

Eligibility 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

Donor:

• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jakob Passweg, Prof. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel, Basel Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Matyas Ecsedi, MD-PhD

Role: CONTACT

matyas.ecsedi@usb.ch

+41612652525

Facility Contacts

Matyas Ecsedi, MD-PhD

Role: primary

matyas.ecsedi@usb.ch

+41612652525

Other Identifiers

Haplo-NK-DLI for AML/MDS

Identifier Type: -

Identifier Source: org_study_id