NCT04327037

Safety of Expanded Haploidentical Natural Killer Cells for Leukemia

Completed Phase 1 Last updated 2 March 2022

What this trial tests

Phase 1 trial testing Expanded Haploidentical Natural Killer cells in Leukemia, Acute Myeloid in 10 participants. Completed in 30 June 2021.

Timeline

2 January 2019

Primary endpoint
6 June 2021

30 June 2021

Quick facts

Lead sponsor	Belarusian Research Center for Pediatric Oncology, Hematology and Immunology
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	2 January 2019
Primary completion	6 June 2021
Estimated completion	30 June 2021
Sites	1 location across Belarus

Drugs / interventions tested

• Expanded Haploidentical Natural Killer cells — full drug profile →
• IL-2 — full drug profile →

Conditions studied

• Leukemia, Acute Myeloid — all drugs for Leukemia, Acute Myeloid →
• Leukemia, Acute Lymphoblastic — all drugs for Leukemia, Acute Lymphoblastic →

Sponsor

Belarusian Research Center for Pediatric Oncology, Hematology and Immunology — full company profile →

Who can join

Adults 1 to 30, any sex, with Leukemia, Acute Myeloid or Leukemia, Acute Lymphoblastic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to estimate the safety of ex vivo expanded haploidentical natural killer (NK) cells for patients with leukemia.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. NK cell-based cancer immunotherapy: from basic biology to clinical development.
   Liu S, Galat V, Galat Y, Lee YKA, et al · · 2021 · cited 504× · PMID 33407739 · DOI 10.1186/s13045-020-01014-w
2. Natural killer cells and acute myeloid leukemia: promises and challenges.
   Rahmani S, Yazdanpanah N, Rezaei N. · · 2022 · cited 20× · PMID 35639116 · DOI 10.1007/s00262-022-03217-1
3. Paving the Way for Immunotherapy in Pediatric Acute Myeloid Leukemia: Current Knowledge and the Way Forward.
   Koedijk JB, van der Werf I, Calkoen FG, Nierkens S, et al · · 2021 · cited 12× · PMID 34503174 · DOI 10.3390/cancers13174364
4. Phenotypic and functional characterisation of locally produced natural killer cells ex vivo expanded with the K562-41BBL-mbIL21 cell line.
   Shman TV, Vashkevich KP, Migas AA, Matveyenka MA, et al · · 2023 · cited 6× · PMID 36527513 · DOI 10.1007/s10238-022-00974-2
5. Phenotypic and functional characterisation of locally produced natural killer cells ex vivo expanded with the K562-41BBL-mbIL21 cell line
   Shman T, Vashkevich K, Migas A, Matveyenka M, et al · · 2022 · DOI 10.21203/rs.3.rs-1822963/v2