Adoptive T Lymphocyte Administration for Chronic Norovirus Treatment in Immunocompromised Hosts
Children's National Research Institute
Summary
This is a Phase I dose-escalation study to evaluate the safety of norovirus -specific T-cell (NST) therapy for chronic norovirus infection in participants following hematopoietic stem cell transplantation (HSCT) or who are immunocompromised due to PID and have not undergone HSCT, or Solid Organ Transplant (SOT) recipients.
Description
This is an open label, phase I study of norovirus-specific T-cell immunotherapy for treatment of participants with primary immunodeficiency disorders (PID) and chronic norovirus. This study is designed to assess the safety of norovirus-specific T-cell (NST) infusion in this population. There are two arms in this study: 1. Arm A: Participants who receive donor derived NST therapy after HSCT 2. Arm B: Participants who receive partially HLA matched NSTs. The following participants apply: * Participants with PID who have not undergone HSCT. * Participants who have undergone HSCT but do not…
Eligibility
- Age range
- 0–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participant Inclusion Criteria for NST Infusion: 1. Participants must meet one of the following criteria: 1. Recipient of prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant using either bone marrow or peripheral blood stem cells or single or double cord blood OR 2. Primary immunodeficiency disorder (as defined by clinical and laboratory evaluations)81 and have not undergone HSCT, OR 3. Recipients of solid organ transplant. 2. Documentation of chronic norovirus infection: a. Chronic norovirus infections will be defined as h…
Interventions
- BiologicalNorovirus -specific T-cell (NST) therapy
Arm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion. Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.
Locations (3)
- Children's National HospitalWashington D.C., District of Columbia
- Johns Hopkins UniversityBaltimore, Maryland
- National Institutes of Health (NIH)Bethesda, Maryland