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New treatment option for CMV Viremia
Official title Expansion of Virus-Specific Lymphocytes for Cell Therapy
ClinicalTrials.gov ID: NCT06011486
What this study is testing
What is Lymphocyte infusion (ImmuneCellVir-I)?
Lymphocyte infusion (ImmuneCellVir-I) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cmv viremia.
Also referred to as CMV-specific cells infusion.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation. In this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Be able to provide signed informed consent.
- Must be between 18 and 75 years old at the time of signing the consent form
- Having undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood transplant)
- Negative pregnancy test for women of childbearing age (non-fertile age defined as post-menopausal over one year, or surgically sterilized)...
- Present with clinically significant CMV infection and one of the following conditions:
You likely can't join if
- Patients who do not meet the inclusion criteria
- Patients who do not agree to participate in the study or sign the consent form
- Patients reporting allergy to murine antibodies or iron-dextran
- Patients with grade 3 or 4 graft versus host disease/graft versus host disease in activity/treatment
- Pregnant or lactating patients
- Patients with uncontrolled bacterial and/or fungal infections
See the full eligibility criteria
- Be able to provide signed informed consent.
- Must be between 18 and 75 years old at the time of signing the consent form
- Having undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood transplant)
- Negative pregnancy test for women of childbearing age (non-fertile age defined as post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women...
- Present with clinically significant CMV infection and one of the following conditions:
- Refractory CMV infection, defined as over a 1log increase in blood or plasma CMV copies number after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)
- Probable refractory CMV infection, defined as persistence of CMV DNA in blood or plasma at the same level or under 1 log increase after 2 weeks of treatment with appropriate anti-CMV medication (treatment with...
- Presence of resistant CMV, defined by the presence of a known genetic mutation that reduces susceptibility to one or more antiviral medications
- Refractory CMV disease, defined as worsening of signs and symptoms and/or progression to CMV disease after 2 weeks of appropriate antiviral therapy
- Restrictions or complications related to conventional therapy, which make it impossible to carry out conventional drug treatment defined as cytopenias with neutrophils under 1000 per microliter, platelets under 100,000...
- Patients who do not meet the inclusion criteria
- Patients who do not agree to participate in the study or sign the consent form
- Patients reporting allergy to murine antibodies or iron-dextran
- Patients with grade 3 or 4 graft versus host disease/graft versus host disease in activity/treatment
- Pregnant or lactating patients
- Patients with uncontrolled bacterial and/or fungal infections
The study team makes the final eligibility decision.
Where it's taking place
- São Paulo, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include São Paulo, São Paulo, Brazil. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.