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Cytomegalovirus Infections clinical trials

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NCT ID: NCT05183490 Recruiting - Clinical trials for Cytomegalovirus Infections

R-MVST Cells for Treatment of Viral Infections

Start date: May 3, 2022
Phase: Phase 1
Study type: Interventional

The primary objective is to determine the safety and feasibility of administering R-MVST cells to patients with refractory viral reactivation and/or symptomatic disease caused by Epstein Barr Virus (EBV), cytomegalovirus (CMV), adenovirus (ADV) or BK virus. R-MVST cells will be generated on-demand from the closest partially human leukocyte antigen (HLA)-matched (minimum haploidentical) healthy donors or from the original allo-transplant donor if available. The investigator will closely monitor the recipients for potential toxicities including graft-versus-host disease (GVHD) post-infusion. Secondary objectives are to determine the effect of R-MVST infusion on viral load, possible recovery of antiviral immunity post-infusion and for evidence of clinical responses and overall survival. Recipients will be monitored for secondary graft failure at day 28 post R-MVST infusion.

NCT ID: NCT05140187 Recruiting - Clinical trials for CMV Infection After Allogenic HSCT

CMV-TCR-T Cells for CMV Infection After Allogenic HSCT

Start date: October 15, 2021
Phase: Phase 1
Study type: Interventional

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating CMV virus infection after allogenic HSCT.

NCT ID: NCT05101213 Recruiting - Clinical trials for Malignant Solid Neoplasm

Study Assessing the Feasibility, Safety and Efficacy of Genetically Engineered Glucocorticoid Receptor Knock Out Virus Specific CTL Lines for Viral Infections in Immunosuppressed Cancer Patients

Start date: January 6, 2023
Phase: Phase 1
Study type: Interventional

This phase I trial tests the feasibility and safety of genetically modified cytotoxic T-lymphocytes in controlling infections caused by adenovirus (ADV), BK virus (BKV), cytomegalovirus (CMV), JC virus (JCV), or COVID-19 in immunocompromised patients with cancer. Viral infections are a leading cause of morbidity and mortality after hematopoietic stem cell transplantation, and therapeutic options for these infections are often complicated by associated toxicities. Genetically modified cytotoxic T-lymphocytes (CTLs) are designed to kill a specific virus that can cause infections. Depending on which virus a patient is infected with (ADV, BKV, CMV, JCV, or COVID-19), the CTLs will be designed to specifically attack that virus. Giving genetically modified CTLs may help to control the infection.

NCT ID: NCT05091177 Recruiting - Clinical trials for Cytomegalovirus Infections

Study on Correlation Between Cytomegalovirus and Ocular Myasthenia Gravis

Start date: January 1, 2021
Phase:
Study type: Observational [Patient Registry]

Ocular myasthenia gravis (OMG) is an autoimmune neuromuscular disease mediated by pathogenic autoantibodies. Its etiology and pathogenesis are not completely clear. The occurrence and development of OMG are the result of the joint participation of genetic factors, environmental factors and immune factors. The role of infectious factors in the pathogenesis of autoimmune diseases is a hot topic in the international discussion.By analyzing the difference in the positive rate and titer of CMV antibodies between ocular myasthenia gravis and healthy people. By analyzing the correlation between the positive rate and titer of CMV antibodies and ocular myasthenia gravis clinical manifestations, acetylcholine receptor antibodies, ESR, hypersensitive C-reactive protein, complement C3, complement C4 and thymus status.To investigate the correlation between cytomegalovirus and ocular myasthenia gravis. It can provide new insights for further studies on the etiology and possible pathogenesis of ocular myasthenia gravis.

NCT ID: NCT05089838 Recruiting - Clinical trials for Allogeneic Hematopoietic Stem Cell Transplantation

CMV-TCR-T Cells for Refractory CMV Infection After HSCT

Start date: January 6, 2021
Phase: Phase 1
Study type: Interventional

This is a single centre, single arm, open-label, phase I study to evaluate the safety and effectiveness of CMV-TCR-T cell immunotherapy in treating refractory CMV infection after HSCT.

NCT ID: NCT04934527 Recruiting - Clinical trials for Kidney Transplantation

Association of T Gamma Delta-CD16+ Cells and Anti-CMV Immunoglobulins in the Prevention of CMV Infection

SYNTAGME
Start date: November 17, 2021
Phase: Phase 2
Study type: Interventional

CMV infection in transplantation remains the most frequent infectious complication causing increased morbidity and mortality. International recommendations advocate prevention of this infection by instituting direct antiviral treatment or monitoring viral replication by PCR with the start of curative antiviral treatment when the DNAemia is positive. The risk of CMV infection varies according to the serostatus of the donor (D) and recipient (R) at the time of transplantation. In the absence of prophylaxis, CMV infection occurs in 60-80% of D+R-, 50-60% of D+R+ and 25-50% of D-R+. The humoral anti-CMV response is represented by the production of antibodies to envelope proteins (gB and gH) and to molecules involved in viral attachment and entry into target cells. However, the majority of CMV-specific antibodies do not have antiviral neutralising activity. The investigators have identified a new player in the specific anti-CMV response expressing the Fc RIIIa receptor (CD16), that interacts with anti-CMV immunoglobulins (Ig): the Tgamma-delta V delta 2-negative lymphocyte (LTgdVd2neg). This lymphocyte subpopulation shows persistent expansion in the peripheral blood of kidney transplant patients with CMV infection. These cells express an effector-memory phenotype (CD45RA+/CD27-). This expansion is associated with resolution of infection in patients. The investigators have shown that CD16 is specifically and constitutively expressed on the surface of CMV-induced LTgdVd2neg in healthy volunteers and kidney transplant patients. The investigators have observed that one of the antiviral activities of anti-CMV IgG lies in its binding to the Fc RIIIa receptor (CD16) on the surface of LTgdVd2neg. The anti-CMV IgGs capturing virions thus activate CD16+ LTgdVd2neg with production of IFN interferon which in turn is responsible for inhibition of CMV viral multiplication. Anti-CMV IgG is a recommended therapeutic option, with a marketing authorisation for the prevention of CMV infection in kidney transplantation in Europe and a Temporary Authorisation for Use in France. Thus, R+ patients expressing a significant level of LTgdVd2neg CD16+ at D0 of transplantation could be protected against CMV, in the absence of direct antiviral treatment by the addition of anti-CMV Ig.

NCT ID: NCT04832607 Recruiting - Clinical trials for Stem Cell Transplant Complications

Multivirus-specific T-cell Transfer Post SCT vs AdV, CMV and EBV Infections

TRACE
Start date: August 27, 2019
Phase: Phase 3
Study type: Interventional

Haematopoietic stem cell transplantation (HSCT) can expose patients to a transient but marked immunosuppression, during which viral infections are an important cause of morbidity and mortality. Adoptive transfer of virus-specific T cells is an attractive approach to restore protective T-cell immunity in patients with refractory viral infections after allogeneic HSCT. The aim of this Phase III trial is to confirm efficacy of this treatment in children and adults.

NCT ID: NCT04822142 Recruiting - Neonatal Disease Clinical Trials

Congenital CYtoMEgalovirus Infection in VIEtnam (CYMEVIE)

CYMEVIE
Start date: April 1, 2022
Phase:
Study type: Observational [Patient Registry]

To estimate the prevalence of congenital CMV infection in Vietnamese neonates and relating morbidity within 2-year follow-up. Along with evaluating the predictive value of the presence and the level of CMV replication in the first trimester in a highly seropositive population

NCT ID: NCT04690933 Recruiting - Clinical trials for Cytomegalovirus Infections

AntiCMV molécules Monitoring in Real-life in Stem Cell Recipients

NAViRe
Start date: September 24, 2020
Phase:
Study type: Observational

Cytomegalovirus (CMV) is a ubiquitous herpesvirus that represent a major cause of morbidity in haematopoietic stem cell transplants (HSCT) recipients, mostly through reactivation of the recipient's virus. If left untreated, 40 to 80% of patients will develop CMV infection, leading to CMV disease in 30 to 35 % patients, and associated with considerable morbi-mortality. Interstitial pneumonia is the most severe and specific manifestation, although CMV replication by itself has also indirect effects such as triggering graft versus host disease and increasing immunosuppression. The current burden of CMV infection increases by 25 to 30% the cost of the graft in France. This also includes the burden for refractory - infections, that represent up to 13% of recipients with CMV infection, including 3% of cases with virological resistance in France (data from the Reference Center cohorts). Ganciclovir, or valganciclovir preemptive treatment, guided by CMV viral load follow-up allowed significant reduction of CMV disease to 2-6% but did not prevent CMV indirect effects. In addition, hematotoxicity can compromise post-transplant haematological reconstitution, thus preventing its use as prophylaxis in France. Foscarnet, iv-administered and nephrotoxic, remains less used. There is thus a high expectation from less toxic molecules for prophylaxis The development letermovir recently available for prophylaxis of CMV infection in high risk patients will modify the patients care and follow-up. This new molecule targeting CMV terminases (developed by Merck) was recently marketed in France (Jan 2020). However, the analysis of the letermovir phase III study and further publications show that the risk of emergence of resistance is low, but may occur in case of breakthrough and thus post AMM monitoring is required. A "real-life" evaluation of these new molecules in terms of efficacy, emergence of resistance, tolerance and morbimortality related to CMV infection, is useful, to propose recommendations on management strategies, in particular for the most at-risk patients i.e. CMV-seropositive recipients. To this purpose, the National Reference Center in collaboration with the French Society for marrow graft and cell therapy (SFGMTC) set up a cohort of surveillance of allografted patients, receiving, in prevention or treatment, old and new molecules.

NCT ID: NCT04615715 Recruiting - Clinical trials for Cytomegalovirus Congenital

Prenatal Behavioral Intervention to Prevent Maternal Cytomegalovirus (CMV) in Pregnancy

Start date: January 11, 2021
Phase: N/A
Study type: Interventional

This study will evaluate whether a brief prenatal clinic-based cytomegalovirus (CMV) risk-reduction behavioral intervention will prevent maternal CMV infections during pregnancy in women.