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

NCT06727383 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2024-12-10

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Donors
  • Myeloproliferative Diseases
  • Lymphoproliferative Disorders

Interventions

PROCEDURE

peripheral blood collection

standard blood test procedures

PROCEDURE

leukapheresis

Leukapheresis is the procedure that allows the separation and collection of hematopoietic stem cells (HSCs) from peripheral blood. The collection takes place through a machine called a "cell separator": it uses centrifugal force to separate the mononuclear cells from all the other cells in the blood and plasma.

Sponsors & Collaborators

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Enrico Derenzini, MD · Istituto Europeo di Oncologia

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-21
Primary Completion
2025-12-21
Completion
2025-12-21

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06727383 on ClinicalTrials.gov