Status:
RECRUITING
Expansion of Virus-Specific Lymphocytes for Cell Therapy
Lead Sponsor:
Hospital Israelita Albert Einstein
Conditions:
CMV Viremia
CMV
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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 complicatio...
Detailed Description
The proposed clinical trial is a phase I single-arm infusion study of cytomegalovirus (CMV)-specific lymphocytes derived from buffy-coat derivatives of platelet donors (ImmuneCellVir-I). T lymphocytes...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 10 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06011486
Start Date
June 10 2024
End Date
June 10 2026
Last Update
October 24 2024
Active Locations (1)
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1
Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil, 05653000