Expansion of Virus-Specific Lymphocytes for Cell Therapy

Launched by HOSPITAL ISRAELITA ALBERT EINSTEIN · Aug 21, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new way to treat patients who have a serious infection caused by a virus called cytomegalovirus (CMV), especially those who have recently had a bone marrow transplant. The researchers are planning to use special immune cells, known as T lymphocytes, taken from healthy blood donors. These cells will be specifically chosen to target CMV and will be given to patients who haven't responded well to standard treatments. This approach aims to help patients recover from CMV infections, which can lead to severe complications and longer hospital stays.

To participate in this trial, individuals must be between 18 and 75 years old and have received a bone marrow transplant. They should also have a significant CMV infection that hasn't improved with regular antiviral medications, or they may have other issues that make standard treatment unsafe. Participants will receive the specially prepared T cells and will be monitored closely throughout the study. This trial could potentially offer a new treatment option for those struggling with CMV after a transplant, which might reduce their risk of complications and shorten their time in the hospital.

Gender

ALL

Eligibility criteria

• 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