Trials / Recruiting
RecruitingNCT05334693
Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children/Young Adults With AML
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Belarusian Research Center for Pediatric Oncology, Hematology and Immunology · Academic / Other
- Sex
- All
- Age
- 6 Months – 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children/young adults with intermediate risk AML.
Detailed description
Immunotherapy with NK cells may improve the treatment results in AML. For better efficiency high cell doses or several infusions of NK cells are required. For this purpose, donor NK cells are expanded in the presence of feeder K562-mbIL21-41BBL cell line. The cycle of immunotherapy includes chemotherapy (cyclophosphamide, fludarabine) followed by two doses of NK cells infusion.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Expanded haploidentical NK cells | Two doses of expanded haploidentical NK cells (30-100 x 10\^6 cells /kg). |
Timeline
- Start date
- 2021-11-01
- Primary completion
- 2025-12-01
- Completion
- 2026-06-01
- First posted
- 2022-04-19
- Last updated
- 2024-08-28
Locations
1 site across 1 country: Belarus
Source: ClinicalTrials.gov record NCT05334693. Inclusion in this directory is not an endorsement.