Acute Myeloid LeukemiaPhase 1/2NCT03300492
Expanded Natural Killer Cells Following Haploidentical HSCT for AML/MDS
A Phase 1/2 study testing NK-DLI in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- What is being tested?
- NK-DLI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Nov 2018to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Basel
Basel, 4031
Matyas Ecsedi, MD-PhD, +41612652525, matyas.ecsedi@usb.ch
About this study
Official title: 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
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
- Being tested
- NK-DLI
- Keywords
- Natural Killer cells, NK cells, Immunotherapy, haploidentical hematopoietic stem cell transplantation
- Medical subject headings
- Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK-DLIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| NK-DLI | Experimental | Preemptive immunotherapy with ex vivo expanded NK cells on days
+10, +15 and +20 with increasing NK cell doses following haplo-HSCT. Receives: Other: NK-DLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events including GvHD and infections.
As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.
Measured: 1 year following haplo HSCT
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: 1 year following haplo HSCT
Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT
rejection.
Measured: 1 year following haplo HSCT
Incidence of graft rejection
Measured: 1 year following haplo HSCT
Number of NK cells given per kg body weight
Measured: 30 days following haplo-HSCT
Number of NK-DLI infusions applied
Measured: 30 days following haplo-HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start12 Nov 2018
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single center, open-label, single arm study
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jakob Passweg, Prof. MD, Principal investigator, University Hospital Basel, Basel Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300492
- Sponsor's protocol ID
- Haplo-NK-DLI for AML/MDS
- Status last verified
- Dec 2025
- First submitted
- 30 Jul 2017
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03300492
- Acronym / sponsor ID
- Haplo-NK-DLI for AML/MDS
- Conditions
- Acute Myeloid Leukemia, Myelodysplastic Syndromes
- Keywords
- Natural Killer cells, NK cells, Immunotherapy, haploidentical hematopoietic stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 12 Nov 2018 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single center, open-label, single arm study
| Arm | Type | Receives |
|---|---|---|
| NK-DLI | Experimental | Other: NK-DLIPreemptive immunotherapy with ex vivo expanded NK cells on days +10, +15 and +20 with increasing NK cell doses following haplo-HSCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- >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
Key exclusion criteria (7 listed)
- APL diagnosis
- Presence of relevant (mean fluorescence intensity >2000) donor-specific anti-HLA antibodies
- Pregnancy
- Necessity of immunosuppression apart from GvHD prophylaxis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK-DLIApplication 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. | Other | NK-DLI |
Primary outcome
Incidence and severity of adverse events including GvHD and infections.
Time frame: 1 year following haplo HSCT
As defined by the CTCAE version 4.03 and the NIH Scoring of GvHD.
5 secondary outcomes
Progression-free survival (PFS)
Time frame: 1 year following haplo HSCT
Incidence of AML/MDS-EB complete morphological and molecular remission (CR) at day + 30, + 90, +180 and 1 year post allo-HSCT
Time frame: 1 year following haplo HSCT
Incidence of graft rejection
Time frame: 1 year following haplo HSCT
Number of NK cells given per kg body weight
Time frame: 30 days following haplo-HSCT
Number of NK-DLI infusions applied
Time frame: 30 days following haplo-HSCT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jakob Passweg, Prof. MD principal investigator
University Hospital Basel, Basel Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NK-DLI in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Matyas Ecsedi, MD-PhD (+41612652525, matyas.ecsedi@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events including GvHD and infections. (time frame: 1 year following haplo HSCT). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.