NCT05686538 Innate Donor Effector Allogeneic Lymphocyte Infusion After Stem Cell Transplantation: the IDEAL Trial
| NCT ID | NCT05686538 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Rigshospitalet, Denmark |
| Condition | AML/MDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2022-01-01 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The curative principle behind allogeneic hematopoietic stem cell transplantation (HSCT) is eradication of the malignant cells of the patient (recipient) by donor graft cells, a process termed graft-versus-leukemia (GVL) effect. GVL is traditionally mediated by donor αβ T cells in an immunological process driven by genetical differences between individuals, i.e. an allogeneic response. For this reason, αβ T cells also cause an unwanted and dangerous complication of HSCT called graft-versus-host disease (GVHD) in which healthy recipient cells are targeted by donor cells with great risk of morbidity and mortality to the patient. In addition to αβ T cells, other cells from the donor stem cell graft, termed innate effector lymphocytes, can contribute to the GVL effect. These are termed natural killer (NK) cells and T-cell receptor (TCR) γδ cells, the latter being a subset of T cells. NK and TCR γδ cells can recognize and eliminate leukemic cells in a direct tumor response independent of conventional allogeneicity. Therefore, opposite αβ T cells, innate effector lymphocytes cells can mediate GVL but are not likely to cause GVHD. The main indications for HSCT in adults are acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Approximately 50% of AML/MDS transplant patients experience significant acute GVHD and 30% experience relapse of the malignant disease. Prospective clinical studies from the research group of the investigators have shown that patients with high doses of innate lymphocytes in stem cell grafts and during early immune reconstitution after HSCT have a reduced risk of both GVHD and relapse. The aim of this clinical trial is therefore to administer innate donor lymphocyte infusion (iDLI) enriched in NK and TCR γδ cells and depleted of αβ T cells in patients early after HSCT. By improving the HSCT procedure with iDLI cell therapy the scope is less GVHD and less relapse of the malignant disease and thereby improved survival and life quality in AML/MDS patients.
Eligibility Criteria
Inclusion Criteria: * Diagnoses: AML, MDS * Age: ≥18 years * Graft type: PBSC * Donor: ≥18 years * Informed consent from both donor and recipient Exclusion Criteria: • Donors with need for central venous access for the leukapheresis procedure
Contact & Investigator
Lia Minculescu, MD, PhD
STUDY DIRECTOR
Department of Clinical Immunology, Rigshospitalet, Copenhagen.
Frequently Asked Questions
Who can join the NCT05686538 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying AML/MDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05686538 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05686538 currently recruiting?
Yes, NCT05686538 is actively recruiting participants. Contact the research team at lia.minculescu@regionh.dk for enrollment information.
Where is the NCT05686538 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT05686538 clinical trial?
NCT05686538 is sponsored by Rigshospitalet, Denmark. The principal investigator is Lia Minculescu, MD, PhD at Department of Clinical Immunology, Rigshospitalet, Copenhagen.. The trial plans to enroll 80 participants.