Clinical trial · Interventional
Natural Killer-cell Therapy for Acute Myeloid Leukemia
Infusion of ex Vivo-generated Allogeneic Natural Killer Cells in Combination With Subcutaneous IL-2 in Patients With Acute Myeloid Leukemia: a Phase I/IIa Study
NCT04347616CI-TRIAL-00105568NK4AMLterminatedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Stop funding
Summary
Brief summary (as posted)
This study investigates an innovative treatment for relapsed or refractory acute myeloid leukemia exploiting administration of ex vivo-generated allogeneic natural killer (NK) cells with preceding non-myeloablative conditioning chemotherapy with or without subsequent in vivo IL-2 cytokine support.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia Refractory | — | UNRESOLVED | — |
| Acute Myeloid Leukemia, Relapsed, Adult | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IL-2 | Drug | — | UNRESOLVED |
| UCB-NK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NK cells without IL-2
- description
- On day 0, patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic UCB-NK cells. Prior to NK cell infusion, patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. NK cells administration will not be followed by sc IL-2. N=3.
- interventionNames
- Biological: UCB-NK cells
- type
- ACTIVE_COMPARATOR
- label
- NK cells with low dose IL-2
- description
- On day 0, patients will receive a fixed dose of 1.0-3.0 x 10\^9 allogeneic UCB-NK cells. Prior to NK cell infusion, patients will receive cyclophosphamide and fludarabine (Cy/Flu) based lymphodepleting chemotherapy. IL-2 will be administered in a fixed dose of 3.0 x 10\^6 units starting 4 hours after NK cell infusion and given every other day for 6 doses in total. N=3
- interventionNames
- Biological: UCB-NK cells
- Drug: IL-2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * AML patients (de novo and secondary) or patients with MDS excess blasts-2 according to WHO criteria 2016, who have stable disease or non-rapidly progressive disease with or without disease controlling medication who are (at time of inclusion) ineligible for allo-SCT. * Patients may belong to any of the following categories: * Relapsed/refractory disease after treatment with intensive chemotherapy, hypomethylating agents, targeted agents, autologous or allo-SCT (at least 6 months ago) and DLI * Newly diagnosed, untreated patients ineligible for allo-SCT Other inclusion criteria: * Age ≥ 18 years * WHO performance 0-2 * Life expectancy of \> 4 months * Written informed consent * Hydrea is allowed as pre-treatment to control blast count until day -3 * Other disease controlling medication is allowed until day -7 Exclusion Criteria: * Progressive disease according to ELN criteria in case of previous therapy * Patients on immunosuppressive drugs or active GvHD * Patients with active infections (viral, bacterial or fungal); acute anti-infectious therapy must have been completed within 14 days prior to study treatment * Severe cardiovascular disease (CTCAE III-IV) * Severe pulmonary dysfunction (CTCAE III-IV) * Severe renal dysfunction (CTCAE III-IV) * Severe hepatic dysfunction (CTCAE III-IV) * Severe neurological or psychiatric dysfunction (CTCAE III-IV) * Patients on concurrent chemotherapy or interferon-alpha treatment * Pregnancy or breastfeeding
References
Publications (1)
- RESULTDolstra H, Roeven MWH, Spanholtz J, Hangalapura BN, Tordoir M, Maas F, Leenders M, Bohme F, Kok N, Trilsbeek C, Paardekooper J, van der Waart AB, Westerweel PE, Snijders TJF, Cornelissen J, Bos G, Pruijt HFM, de Graaf AO, van der Reijden BA, Jansen JH, van der Meer A, Huls G, Cany J, Preijers F, Blijlevens NMA, Schaap NM. Successful Transfer of Umbilical Cord Blood CD34+ Hematopoietic Stem and Progenitor-derived NK Cells in Older Acute Myeloid Leukemia Patients. Clin Cancer Res. 2017 Aug 1;23(15):4107-4118. doi: 10.1158/1078-0432.CCR-16-2981. Epub 2017 Mar 9. PMID 28280089