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RECRUITING

NCT06011486

PHASE1

Expansion of Virus-Specific Lymphocytes for Cell Therapy

Sponsor: Hospital Israelita Albert Einstein

View on ClinicalTrials.gov

Summary

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. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private. This project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity / mortality after transplantation, as well as a reduction in the hospitalization period.

Official title: Expansion of Virus-Specific Lymphocytes for Cell Therapy in Immunosuppressed Patients Who Underwent Bone Marrow Transplantation.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-10

Completion Date

2026-06-10

Last Updated

2024-10-24

Healthy Volunteers

Conditions

CMV Viremia CMV

Interventions

COMBINATION_PRODUCT

Lymphocyte infusion (ImmuneCellVir-I)

Infusion of donor CMV specific cells into patients eligible to the trial

Inclusion 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 of childbearing age; * 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 ganciclovir, valganciclovir, or foscarnet) * 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 per microliter related to the use of ganciclovir or valganciclovir and nephrotoxicity with an increase of 1.5 times in the baseline creatinine with the use of foscavir. Exclusion Criteria: * 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

Locations (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil