Clinical trial · Interventional
Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
Haploidentical Donor Cytokine-Induced Memory-Like Natural Killer Cells (CIML-NK) for Relapsed & Refractory Acute Myeloid Leukemia (AML)
NCT05580601CI-TRIAL-00104024recruitingPhase 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
Summary
Brief summary (as posted)
The objective of this study is to demonstrate that cytokine-induced memory-like natural killer cells can be generated from donor cells and infused safely into patients with relapsed or refractory acute myeloid leukemia (AML). A secondary objective is to assess efficacy of the CIML-NK cells in treating AML.
Conditions
Conditions (1)
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 | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CIML-NK Cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cytokine-Induced Memory-Like Natural Killer (CIML-NK) Cells
- description
- The investigational cell product is a cytokine-induced memory-like natural killer cell preparation, derived from the recipient's haploidentical donor's apheresis product.
- interventionNames
- Drug: CIML-NK Cells
Primary outcomes (1)
- measure
- Feasibility of infusion
- timeFrame
- 30 days
- description
- Number of patients who receive CIML-NK infusion without grade 3-4 infusional toxicity events as assessed by CTCAE v5.0 divided by the number of patients enrolled.
Secondary outcomes (3)
- measure
- Clinical Response to CIML-NK Infusion
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
Show eligibility criteria text
Inclusion Criteria: * Of age ≥ 2 years of age at the time of study enrollment * With AML diagnosed per 2016 WHO criteria (11) * With relapsed or refractory AML in their bone marrow * Refractory disease: Patients must have ≥ 5% blasts in the bone marrow after 2 courses of intensive induction treatment * Relapsed disease: Patients must have ≥ 5% blasts in the bone marrow, or reappearance of blasts in the blood, within 6 months of initial CR * With available haploidentical related donors. Donor specific antibody (DSA) testing will be done on the recipient prior to or upon enrollment. * With performance level of ≥ 50% on Karnofsky scale for patients \> 16 years of age and ≥ 50% on Lansky scale for patients ≤ 16 years of age Exclusion Criteria: * Disease: isolated central nervous system (CNS) disease, or isolated extramedullary disease, or diagnosis of acute promyelocytic leukemia (APML). Patients with extramedullary disease in combination with bone marrow disease are eligible for enrollment. * Infectious Disease: Active uncontrolled infection * Cardiac function: Systolic ejection fraction \<45% by echocardiogram * Pulmonary Function: Oxygen saturation \<92% on room air * Hepatic function: Total bilirubin \> 2mg/dL, AST and ALT more than three times the upper limit of normal * Concomitant medications: receiving either \>10mg prednisone equivalent daily, or \>0.5mg/kg prednisone equivalent daily, whichever is less * Concomitant investigational treatments: receiving other investigational therapies * Known allergy or hypersensitivity reaction to IL-2 injections * Pregnant or breastfeeding women will not be entered on this study due to risks of fetal and teratogenic adverse events with lymphodepleting chemotherapy. Pregnancy tests must be obtained for female patients. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion. Effective contraceptive methods include oral contraceptive pills, patches, or injections, intrauterine devices, having a tubal ligation, having a partner who has had a vasectomy, or not having sex.
References
Publications (0)
Data not yet available
No reference posted for this study.