Using T Cell Therapy to Treat Adenovirus Infection After Stem Cell Transplant
Antigen Specific Adoptive T Cell Therapy for Refractory Opportunistic Adenovirus Infection After a Hematopoietic Stem Cell Transplantation
This study is testing whether using special immune cells from a donor can help treat adenovirus infections in patients who have had a stem cell transplant.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 3 Months and up |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | prednisone, immunotherapy |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT03378102 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients who have undergone allogeneic HSCT and have documented adenovirus infections that have not responded to standard antiviral treatments.
Not a fit: Patients who are not experiencing adenovirus infections or those who have not undergone HSCT may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients suffering from adenovirus infections post-transplant, potentially improving their recovery and survival rates.
How similar studies have performed: While the use of T cell therapy for infections is an emerging field, this specific approach for adenovirus post-HSCT is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Cleveland, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.