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
This study is testing a new treatment using special immune cells from umbilical cord blood to see if it can help people with relapsed or hard-to-treat acute myeloid leukemia.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Radboud University Medical Center Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, fludarabine |
| Locations | 1 site (Nijmegen) |
| Trial ID | NCT04347616 on ClinicalTrials.gov |
What this trial studies
This study investigates a novel treatment for relapsed or refractory acute myeloid leukemia (AML) using ex vivo-generated allogeneic natural killer (NK) cells. Patients will first receive non-myeloablative conditioning chemotherapy, followed by the infusion of NK cells derived from umbilical cord blood. The study consists of two phases: a safety assessment of different doses of IL-2 in phase I, followed by an efficacy evaluation in phase IIa. The goal is to determine the safety and effectiveness of this cellular immunotherapy approach.
Who should consider this trial
Good fit: Ideal candidates include adults with relapsed or refractory AML who are ineligible for allogeneic stem cell transplantation.
Not a fit: Patients with progressive disease or those on immunosuppressive drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat acute myeloid leukemia.
How similar studies have performed: Other studies utilizing natural killer cell therapies have shown promise, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Nijmegen
- Radboud University Medical Center — Nijmegen, Netherlands (Recruiting)
Study contacts
- Principal investigator: N.P.M. Schaap — Department of Hematology
- Study coordinator: P.M.M. van Hauten, MSc
- Email: paulien.vanhauten@radboudumc.nl
- Phone: 0031 24 36 13223
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.