NCT06727383

CAR-NK Cells Production and Expansion From Patients With Lympho or Myeloproliferative Disorders and From Healthy Donors

Status unknown NA Last updated 10 December 2024

What this trial tests

NA trial testing peripheral blood collection in Healthy Donors in 140 participants. Status unknown.

Timeline

21 December 2022

Primary endpoint
21 December 2025

21 December 2025

Quick facts

Lead sponsor	European Institute of Oncology
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	basic science
Enrollment	140
Start date	21 December 2022
Primary completion	21 December 2025
Estimated completion	21 December 2025
Sites	1 location across Italy

Drugs / interventions tested

• peripheral blood collection
• leukapheresis — full drug profile →

Conditions studied

• Healthy Donors — all drugs for Healthy Donors →
• Myeloproliferative Diseases — all drugs for Myeloproliferative Diseases →
• Lymphoproliferative Disorders — all drugs for Lymphoproliferative Disorders →

Sponsor

European Institute of Oncology

Who can join

18 and older, any sex, with Healthy Donors or Myeloproliferative Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Recent studies demonstrated the safety and efficacy of allogeneic and autologous infusion of NK cells as adoptive immunotherapy in malignant hematological diseases and solid tumors.NK cells are innate immunity effectors with antitumor activity regulated by a wide variety of receptors located on their cell surface, with both activating and inhibiting roles.Receptors with an inhibitory role include receptors of the KIRs family (Killer Immunoglobulin like Receptors) and receptors of the CD94 / NKG2A complex and are capable of recognizing molecules of Human Leukocyte Antigen class I (HLA-I). Receptors of the KIRs family are members of the immunoglobulin superfamily and are encoded by highly polymorphic genes located on chromosome 19q13.4 in a region known as a leukocyte receptor cluster (LCR). The predominant ligand for KIRs receptors is HLA-C, but other studies show that HLA-A and HLA-B are also involved. Receptors with an activating role, on the other hand, such as NCRs (Natural Cytotoxic receptors), are specific to NK cells, while other epitopes such as CD 56 are also present on other populations of T lymphocytes.

This receptor condition allows, in patients suffering from haemopathy and undergoing transplantation allogeneic stem cell, an alloreactivity induced by the mismatch between the donor's KIRs and their ligands on recipient target cells and, therefore, the role of NK cells as allogeneic effectors. The engraftment of NK cells has been shown to be correlated with a lower risk of disease recurrence, therefore the therapeutic infusion of NK cells from donors could allow, with benefit, the acquisition of fully functional NK cells in the recipient.

Publications & conference data

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

1. Advances in chimeric antigen receptor-natural killer cell therapy: from mechanisms and preclinical studies to clinical application.
   Ren T, Wang F, Liu X, Guo J, et al · · 2025 · PMID 41635402 · DOI 10.3389/fonc.2025.1759796
2. Chimeric antigen receptor natural killer (CAR-NK) cells: from preclinical promise to clinical reality in cancer immunotherapy.
   Cochran HC, Ghobadi KA, Ghobadi A. · · 2025 · PMID 41186143 · DOI 10.1080/1750743x.2025.2582464