RECRUITING

Antigen Specific Adoptive T Cell Therapy for Adenovirus Infection After Hematopoietic Stem Cell Transplantation

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Conditions

Allogeneic Hematopoietic Stem Cell TransplantationT Cell TherapyOpportunistic Infection

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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 it is possible to treat an infection with a cell-based immunotherapy (therapy that uses the patient's own immune system to treat the infection). This treatment is called adoptive T cell therapy. Another purpose is to learn about the side effects and toxicities of adoptive T cell therapy. Adoptive T cell therapy is an investigational (experimental) therapy that works by using the blood of a donor that has immunity against the virus. The donor cells are collected and then the cells, called T cells, that are capable of defending against the virus are selected out. These selected T cells are then infused back into 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 Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation

Quick Facts

Study Start:2019-01-04
Study Completion:2028-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03378102

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 HSCT and be greater than 30 days post-HSCT at the time of registration.
  2. * Patients must have evidence of documented HAdV infection/reactivation. Patients may be:
  3. * Symptomatic with any detectable viral load OR
  4. * Asymptomatic with viral load that is:
  5. * Patients must have poor response and/or contraindication to therapy:
  6. * Absence of an improvement of viral load (decrease by at least 1 log, i.e. 10-fold) after ≥ 14 days of antiviral therapy with ganciclovir, valganciclovir and/or foscarnet. OR
  7. * New, persistent and/or worsening HAdV-related symptoms, signs and/or markers of end organ compromise while on antiviral therapy with ganciclovir, valganciclovir or foscarnet. OR
  8. * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet.
  9. * Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50
  10. * The effects of virus-specific, antigen-selected T cells on the developing human fetus are unknown. For this reason, 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 who are 14 years and older 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. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with the agents described above, breastfeeding should be discontinued if the mother participates in this trial.
  2. * Patients with opportunistic viral infections other than HAdV.
  3. * Patients with active, grade II-IV, acute graft versus 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.

Contacts and Locations

Study Contact

Mari H Dallas, MD
CONTACT
216-844-0139
mhd27@case.edu

Principal Investigator

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

Study Locations (Sites)

University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Mari Dallas

  • Mari H Dallas, MD, PRINCIPAL_INVESTIGATOR, University Hospitals, Seidman Cancer 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 Date2019-01-04
Study Completion Date2028-12

Study Record Updates

Study Start Date2019-01-04
Study Completion Date2028-12

Terms related to this study

Keywords Provided by Researchers

  • T Cell Therapy
  • Opportunistic Infection

Additional Relevant MeSH Terms

  • Allogeneic Hematopoietic Stem Cell Transplantation