Clinical trial · Interventional
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With AML
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children/Young Adults With High-risk, Refractory or Relapsed AML
NCT05272293CI-TRIAL-00080279unknownPhase 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 purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children/young adults with primary high risk or refractory AML and relapsed 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 |
|---|---|---|---|
| NK cell infusions | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- expanded haploidentical NK cell immunotherapy
- description
- After a cycle of chemotherapy a patient receive three intravenous infusions of expanded haploidentical NK cells.
- interventionNames
- Biological: NK cell infusions
Primary outcomes (3)
- measure
- Objective Response Rate (ORR) (PR+ MLFS+CRi +CR)
- timeFrame
- 30 days after every a course of NK immunotherapy
- description
- The proportion of patients with complete remission (CR), CR with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), and partial remission (PR) as measured by response criteria definitions for acute myeloid leukemia.
- measure
- Leukemia-free survival (LFS)
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 6 Months
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: Patients: * primary high risk AML * primary refractory AML * relapsed AML * Karnofsky or Lansky performance scale greater or equal to 70 * written informed consent Donors: * haploidentical family donor * donor suitable for cell donation and apheresis according to standard criteria * written informed consent Exclusion Criteria: Patients: * uncontrolled infection * severe hepatic dysfunction: SGOT or SCPT \>=5x upper limit of normal for age * positive serology for human immunodeficiency virus (HIV) Donors: * pregnancy * positive serology for HIV, hepatitis B or C
References
Publications (0)
Data not yet available
No reference posted for this study.