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

Launched by MARI DALLAS · Dec 15, 2017

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment option for patients who have developed an adenovirus infection after receiving a stem cell transplant. The treatment being studied is called adoptive T cell therapy. This method uses immune cells from a donor who has immunity against the virus. These cells are specially selected and then given back to the patient to help their immune system fight the infection. The study aims to find out if this treatment is effective and to learn about any side effects that might occur.

To be eligible for this trial, participants must be at least 30 days post-stem cell transplant and have a documented adenovirus infection. They should also have not responded well to standard antiviral treatments or have experienced side effects from them. Participants must be willing to use effective birth control during the study, and those aged 14 and older must be able to understand and sign consent forms. If someone joins the study, they can expect to receive this experimental treatment and will be closely monitored for any effects, both positive and negative. It’s important to note that this therapy is still being researched and is not yet approved by health authorities.

Gender

ALL

Eligibility 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.