Marrow transplanted immunocompromised patients with cytomegalovirus (CMV) viral infection will be treated with CMV activated T-Lymphocytes. T-Lymphocytes will be obtained through an apheresis from a compatible donor. Safety and immunoreconstitution parameters in blood samples will be assessed up to +60 days after the treatment.
A prospective, multicentre, open-label and uncontrolled phase Ib-II clinical trial in which a total of 20 patients ≥ 1 year of age with an allogeneic transplant of hematopoietic progenitors and post-transplant CMV infection will be included. The main objective is to evaluate the safety of the infusion of CMV activated T-lymphocytes and secondary objectives are to evaluate the efficacy through clinical evolution, viral load, ability to induce immunoreconstitution against the virus and evaluation of the persistence of specific T cells. The treatment will be administered intravenously (central or peripheral route) in a single dose at a dose of 0.01-5 E4 specific virus T lymphocytes per Kg of receptor weight. After the infusion, patients will follow periodic controls (+7, +14, +21, +28, +45 and +60 days) in which a clinical evaluation will be performed and blood samples will be obtained in order to evaluate the persistence of specific T cells in the recipient:
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
26
Activated T-Lymphocytes will be infused intravenously in a single-dose
ICO Badalona
Badalona, Barcelona, Spain
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, Spain
ICO l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Safety assessment: Adverse events
Adverse events
Time frame: 60 days
Polymerase chain reaction (PCR)
Quantitative viral load
Time frame: +7, +14, +21, +28, +45, +60 days
IFN-γ+ spot forming cells
Immune reconstitution by Elispot
Time frame: +7, +14, +28, +60 days
Lymphocyte subpopulations
Immune reconstitution by flow cytometry
Time frame: +7, +14, +28, +60 days
T-cell persistence by chimerism
Detection of donor cellularity (administered product) in the receptor serum
Time frame: +14, +28 days
Time elapsed in identifying the donor
Time elapsed between the patient's inclusion in the trial and confirmation of the donor
Time frame: Day 0
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Hospital Vall d'Hebron
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Universitario La Fe
Valencia, Spain