RECRUITING

T Cell Therapy of Opportunistic Cytomegalovirus Infection

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Conditions

Cytomegalovirus InfectionsHematopoietic Stem Cell TransplantOpportunistic InfectionsImmunotherapyT-Cell TherapyLymphoproliferative Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

Antigen Specific Adoptive T Cell Therapy for Opportunistic Cytomegalovirus Infection Occurring After Stem Cell Transplant

Quick Facts

Study Start:2020-05-27
Study Completion:2028-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02982902

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Months
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients must have received allogeneic hematopoietic stem cell transplant and be greater than 30 days post-transplant at the time of registration
  2. * Patients must have documented opportunistic CMV infection, or reactivation; the criteria include (both of the following criteria must be met)
  3. * Patients may have asymptomatic viremia (\>1000 copies/ml) OR presence of symptoms secondary to CMV infection, AND
  4. * Patients must have ONE OF THE NEXT FOUR CRITERIA:
  5. * 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
  6. * 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
  7. * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir or foscarnet.
  8. * Second recurrence of CMV viremia, CMV-related symptoms, signs and/or markers of end organ compromise.
  9. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3
  10. * 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.
  11. * Subjects must have the ability to understand and the willingness to sign a written informed consent document, or assent document.
  1. * Pregnant or breastfeeding women are excluded from this study.
  2. * Patients with opportunistic viral infections other than CMV.
  3. * 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
  4. * Treatment with antithymocyte globulin within 28 days of planned infusion of virus - specific, antigen selected T cells.
  5. * Treatment with virus - specific T cells within 6 weeks (42 days) of planned infusion.
  6. * 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).
  7. * Must have evidence of a serologic response (i.e. be seropositive) against CMV.
  8. * Age ≥ 18 years
  9. * Must meet the criteria for donor selection defined in the Standard Operating Procedures of University Hospitals Seidman Cancer Center Stem Cell Transplant Program
  10. * Must be capable of undergoing a single standard 2 blood volume leukapheresis or donation of one unit of whole blood

Contacts and Locations

Study Contact

Mari H Dallas, MD
CONTACT
1-800-641-2422
CTUReferral@UHhospitals.org

Principal Investigator

Mari H Dallas, MD
PRINCIPAL_INVESTIGATOR
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Locations (Sites)

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
United States

Collaborators and Investigators

Sponsor: Mari Dallas

  • Mari H Dallas, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-27
Study Completion Date2028-08

Study Record Updates

Study Start Date2020-05-27
Study Completion Date2028-08

Terms related to this study

Keywords Provided by Researchers

  • Immunotherapy
  • T-Cell Therapy
  • Lymphoproliferative Disorder

Additional Relevant MeSH Terms

  • Cytomegalovirus Infections
  • Hematopoietic Stem Cell Transplant
  • Opportunistic Infections