Clinical trial · Interventional
Safety of Expanded Haploidentical Natural Killer Cells for Leukemia
Pilot Study of Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Leukemia
NCT04327037CI-TRIAL-00056818completedPhase 1ClinicalTrials.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 safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.
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 |
|---|---|---|---|
| Leukemia, Acute Lymphoblastic | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Leukemia, Acute Myeloid | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Expanded Haploidentical Natural Killer cells | Biological | — | UNRESOLVED |
| IL-2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- NK cells + IL-2
- description
- After cycle of chemotherapy patient receive one intravenous infusion of expanded haploidentical NK cells on day 0. On alternate days, 6 doses of subcutaneous IL-2 is administered with start on day -1.
- interventionNames
- Biological: Expanded Haploidentical Natural Killer cells
- Drug: IL-2
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events
- timeFrame
- 1 months
- description
- Adverse events will be graded according to the CTCAE v4.0
Secondary outcomes (4)
- measure
- Days of persistence of adoptively-transferred haploidentical NK cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 30 Years
Show eligibility criteria text
Inclusion Criteria: Patients: * Relapsed acute myeloid or lymphoblastic leukemia * Primary refractory myeloid or lymphoblastic leukemia * Karnofsky or Lansky performance scale greater or equal to 70 * Written informed consent Donor: * Haploidentical family donor * \> 18 years old * 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 or breast feeding * Positive serology for HIV, hepatitis B or C.
References
Publications (1)
- DERIVEDShman TV, Vashkevich KP, Migas AA, Matveyenka MA, Lasiukov YA, Mukhametshyna NS, Horbach KI, Aleinikova OV. Phenotypic and functional characterisation of locally produced natural killer cells ex vivo expanded with the K562-41BBL-mbIL21 cell line. Clin Exp Med. 2023 Oct;23(6):2551-2560. doi: 10.1007/s10238-022-00974-2. Epub 2022 Dec 17. PMID 36527513