CMV ViremiaPhase 1/2NCT04018261

Virus-specific Activated T Lymphocytes From a Donor in Hematopoietic Progenitor Transplanted Patients

A Phase 1/2 study testing Activated T-Lymphocytes in people with CMV Viremia and Immunosuppression-related Infectious Disease, run by Banc de Sang i Teixits at 7 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: CMV Viremia, Immunosuppression-related Infectious Disease
What is being tested?: Activated T-Lymphocytes
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 7 sitesSpain
Study dates: 4 Jul 2019to 18 Oct 2021
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Recipient of an allogeneic hematopoietic progenitors cell transplant (irrespectively of the donor source, donor type conditioning and underlying disease) that is beyond the day +30 of the procedure
Patient with post-transplant infection due to CMV refractory or resistant to optimal pharmacological treatment. Specifically, the patient must be included in any of the following cases
Patient with organic disease caused by CMV (confirmed by histology) resistant to antiviral first line treatment
Patient with CMV reactivation and no organic disease, resistant or intolerant to 2 previous antiviral treatment lines (ganciclovir/valganciclovir and foscarnet) or not candidate to be treated due to not acceptable expected toxicity (severe renal insufficiency, neutropenia or severe thrombopenia) It is agreed that the patient is affected with a resistant CMV infection if the CMV copies doesn't decrease in > 1 log in total blood or otherwise the absolute number of copies > 1x10E4/mL in total blood after 2 weeks of antiviral treatment.
Patients with reactivation of recurrent CMV despite correct anti-CMV treatment. It will be considered a recurrent CMV infection if the patient has > 2 reactivations in a period <6 months despite having received correct anti-CMV treatment
Documented genetic mutations associated with ganciclovir or foscarnet resistance

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≥ 1 year of age
Estimated life expectancy > 30 days
Signature of the informed consent form

Who cannot join

Acute graft-versus-host disease (GVHD) ≥ grade II or chronic ≥ moderate
Corticosteroid ≥ 0.5mg/kg regardless the indication
Disease relapse at the time of infection or at any time after the Allogeneic transplant.
Severe renal disease (creatinine > 3gr/dL)
Severe hepatic disease (bilirubin >3mg/dL or aspartate aminotransferase (AST) >500 U/L) except if it is secondary to the viral infection.
Having received a donor lymphocytes infusion or any cell therapy product within 60 days prior to inclusion in the study (with the exception of transfusions), or having it planned within the next 60 days.

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Alteration of the general condition, infection or clinical or hemodynamic instability that, in the opinion of the researcher, does not recommend the use of T cells
Known hypersensitivity to murine proteins or iron dextran.
Positive serology to human immunodeficiency virus (HIV), hepatitis B virus (HBV) (HBsAg, HBcAc), hepatitis C virus (HCV) and/or syphilis
Pregnant, lactating or women without adequate contraception
Participation in a clinical trial with investigational medicinal products the last 30 days

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

Spain7 sites

ICO Badalona
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital Sant Joan de Déu
Esplugues de Llobregat, Barcelona, 08950
ICO l'Hospitalet
L'Hospitalet de Llobregat, Barcelona, 08908
Hospital Universitario La Fe
Valencia, 46026

Other trials in Spain

About this study

Official title: A Prospective Multicenter Open-label, Not Controlled Phase Ib-II Clinical Trial to Assess the Safety and Immunologic Efficacy of Virus-specific T Lymphocytes From the Best Donor in Receptors of Hematopoietic Progenitor Allogeneic Transplant

Safety and immunoreconstitution parameters in blood samples will be assessed up to +60 days after the treatment.

Read the detailed description

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:

Conditions: CMV Viremia, Immunosuppression-related Infectious Disease
Being tested: Activated T-Lymphocytes
Keywords: CMV, Bone marrow transplant, Activated T-Lymphocytes, Cell therapy, Virus infection, immunosuppression
Medical subject headings: Virus Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Activated T-LymphocytesDrug
Activated T-Lymphocytes will be infused intravenously in a single-dose

Study groups in NCT04018261
Study group	Role	What they receive
Activated T-Lymphocytes	Experimental	Allogeneic T-Lymphocytes obtained from apheresis activated against CMV. Receives: Drug: Activated T-Lymphocytes

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety assessment: Adverse events
Adverse events
Measured: 60 days

Secondary outcomes (5)

Polymerase chain reaction (PCR)
Quantitative viral load
Measured: +7, +14, +21, +28, +45, +60 days
IFN-γ+ spot forming cells
Immune reconstitution by Elispot
Measured: +7, +14, +28, +60 days
Lymphocyte subpopulations
Immune reconstitution by flow cytometry
Measured: +7, +14, +28, +60 days
T-cell persistence by chimerism
Detection of donor cellularity (administered product) in the receptor serum
Measured: +14, +28 days
Time elapsed in identifying the donor
Time elapsed between the patient's inclusion in the trial and confirmation of the donor
Measured: Day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Jul 201918 Oct 2021

First posted12 Jul 2019
Study start4 Jul 2019
Primary completion18 Oct 2021
Study completion18 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for CMV ViremiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04018261
Sponsor's protocol ID: BST-LT-01
Status last verified: Jan 2024
First submitted: 9 Jul 2019
Last updated: 24 Jan 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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