T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
Children's National Research Institute
Summary
This is an open label, phase I dose-escalation study to evaluate the safety of coronavirus-specific T cell (CST) therapy for prevention of SARS-CoV-2 infection in immunocompromised patients following hematopoietic stem cell transplantation (HSCT). Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \<4 months after HSCT). In this dose escalation trial, three doses (1x107/m2, 2x107/m2, and 4x107/m2) will be tested for safety, with study arms for adult (≥18 years of age and \<80 years) HSCT recipients (Arm A) and two arms for pediatric (≥12 years of age and \<18 years; ≥2 years and \<12 years) HSCT recipients (Arm B and Arm C, respectively), and defined dose escalations in each study arm. The study agent will be assessed for safety (stopping rules defined) and antiviral activity.
Description
The primary purpose of this phase I study is to assess the safety of administering donor-derived CSTs in immunocompromised participants for prevention of SARS-CoV-2 infection. Related and unrelated donors of participants who are at risk of SARS-CoV-2 infection will be enrolled for screening and production of CSTs from peripheral blood. Following product manufacturing, participants who have undergone HSCT will receive donor-derived CSTs for prevention of SARS-CoV-2 infection. It is a dose escalation study with separate study arms for adult (Arm A) and pediatric (Arms B and C) recipients of HSC…
Eligibility
- Age range
- 2–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Participant Inclusion Criteria for CST Infusion: 1. For recipient of CSTs derived from an HSCT donor under Arm A: a. Patients aged ≥18 years and \<80 years who were recipients of prior myeloablative or non-myeloablative allogeneic HSCT using either bone marrow or peripheral blood stem cells or single or double cord blood ≥28 days and \<4 months ago who are at risk of SARS-CoV-2 infection. 2. For recipient of CSTs derived from an HSCT donor under Arms B and C: a. Patients aged ≥2 years and \<18 years who were recipients of prior myeloablative or non-myeloablative a…
Interventions
- BiologicalCoronavirus-specific T cell (CST)
Participants will receive donor-derived CSTs for prevention of SARS-CoV-2 infection after HSCT (≥28 days and \<4 months after hematopoietic stem cell transplantation (HSCT).
Locations (2)
- Children's National HospitalWashington D.C., District of Columbia
- The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins UniversityBaltimore, Maryland