Using T Cell Therapy to Treat Adenovirus Infection After Stem Cell Transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the feasibility of using antigen-specific T cells to treat adenovirus infections that occur after allogeneic hematopoietic stem cell transplantation (HSCT). The approach involves isolating T cells from a donor with immunity against the virus and infusing them into the patient to enhance their immune response. The study will also assess the safety profile and potential side effects of this experimental therapy. Patients will be enrolled in a staggered manner to monitor safety after each infusion.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients must have received allogeneic HSCT and be greater than 30 days post-HSCT at the time of registration.
* Patients must have evidence of documented HAdV infection/reactivation. Patients may be:

  * Symptomatic with any detectable viral load OR
  * Asymptomatic with viral load that is:

\>1000 copies/ml in peripheral blood OR qualitative detection in stool, urine and/or other specimens

* Patients must have poor response and/or contraindication to therapy:

  * 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
  * 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
  * Have contraindications or experience adverse effects of antiviral therapy with ganciclovir, valganciclovir, cidofovir or foscarnet.
* Performance Score: Eastern Cooperative Oncology Group (ECOG) Performance Score ≤ 3. Karnofsky (≥ 16 years) or Lansky (\<16 years) performance score ≥ 50
* 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.
* 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.

Exclusion Criteria:

* 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.
* Patients with opportunistic viral infections other than HAdV.
* 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.
* 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.

Where it's running

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

Study contacts

• Principal investigator: Mari H Dallas, MD — University Hospitals, Seidman Cancer Center, Case Comprehensive Cancer Center
• Study coordinator: Mari H Dallas, MD
• Email: mhd27@case.edu
• Phone: 216-844-0139

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.