Using expanded natural killer cells after haploidentical stem cell transplantation for blood cancers
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
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 |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Drugs / interventions | cyclophosphamide |
| Locations | 1 site (Basel) |
| Trial ID | NCT03300492 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with acute promyelocytic leukemia (APL) or those requiring significant immunosuppression may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Basel
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.