T Cell Therapy of Opportunistic Cytomegalovirus Infection

Launched by MARI DALLAS · Dec 2, 2016

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for patients who have an infection caused by cytomegalovirus (CMV) after receiving a stem cell transplant. The treatment, called adoptive T-cell therapy, uses special immune cells from a donor that are designed to specifically target and fight CMV. Researchers want to see if this approach is safe and effective in helping patients who have persistent or serious CMV infections.

To be eligible for the trial, participants need to have had a stem cell transplant at least 30 days prior and must show evidence of a CMV infection that hasn't improved with standard antiviral medications. Patients will also need to be able to understand the study and provide consent. If you join the trial, you will receive an infusion of the donor's T-cells to enhance your immune response against the infection. It’s important to note that this treatment is still experimental and not yet approved by health authorities.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
• • Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
• • Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
• * Patients must have ONE OF THE NEXT FOUR CRITERIA:
• • Absence of an improvement of viral load after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir or foscarnet (decrease by at least 1 log, i.e. 10-fold) or
• • New, persistent and/or worsening CMV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet, or
• • Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
• • Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
• • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
• • Women of child-bearing potential and men must agree to use adequate contraception (double barrier method of birth control or abstinence) 4 weeks prior to study entry, for the duration of study participation and for 3 months after completing treatment.
• • Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
• Exclusion Criteria:
• • Pregnant or breastfeeding women are excluded from this study.
• • Patients with opportunistic viral infections other than CMV.
• • Patients with active, grade 2-4, acute graft vs. host disease (GVHD), chronic GVHD or any condition requiring high doses of glucocorticosteroid (\>0.5 mg/kg/day prednisone or its equivalent) as treatment
• • Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
• • Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
• • Donor eligibility
• • Related donor of T cells must be at least partially HLA compatible, matching with recipient in at least 3/6 HLA loci (HLA-A, HLA-B, and HLA-DRB1 loci will be considered for this).
• • Must have evidence of a serologic response (i.e. be seropositive) against CMV.
• • Age ≥ 18 years
• • Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
• • Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood