T Cell Therapy of Opportunistic Cytomegalovirus Infection

  • STATUS
    Recruiting
  • End date
    Nov 8, 2023
  • participants needed
    20
  • sponsor
    Mari Dallas
Updated on 8 August 2022
stem cell transplantation
ganciclovir
cell therapy
antiviral therapy
valganciclovir
cmv infection
foscarnet
antiviral drugs
allogeneic hematopoietic stem cell transplant
dhpg
viremia

Summary

The purpose of this study is to determine if a specific type of cell-based immunotherapy, using T-cells from a donor that are specific against cytomegalovirus (CMV) is feasible to treat infections by CMV.

Adoptive T-cell therapy is an investigational (experimental) therapy that works by using the blood of a donor and selecting the T-cells that can respond against a specific infectious entity. These selected T-cells are then infused to the patient, to try to give the immune system the ability to fight the infection. Adoptive T-cell therapy is experimental because it is not approved by the Food and Drug Administration (FDA).

Description

The primary objective of this study is to determine the feasibility of the treatment of opportunistic cytomegalovirus (CMV) infections after hematopoietic stem cell transplant (HSCT) with virus-specific, antigen-selected T-cells, selected using the CliniMACS prodigy system.

Secondary Objective(s)

  • To describe the safety profile of the infusion of CMV- specific, antigen selected T-cells.
  • To describe the toxicities related to infusion of CMV- specific, antigen selected T-cells.
  • To describe the rate of eradication of opportunistic CMV infections after HSCT and and treatment with CMV-specific, antigen-selected T-cells using the CliniMACS Prodigy System.

This feasibility study will include a single treatment cohort.

Details
Condition Cytomegalovirus Infections, Hematopoietic Stem Cell Transplant, Opportunistic Infections
Treatment CMV specific adoptive t-cells
Clinical Study IdentifierNCT02982902
SponsorMari Dallas
Last Modified on8 August 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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