Condition: SARS-CoV-2 Infection · Sponsor: Children's National Research Institute
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.
This description comes directly from the study's public registry record.
Susan Conway, MD · 202-476-5845 · sconway@childrensnational.org
Fahmida Hoq, MBBS · 202-476-3634 · fhoq@childrensnational.org
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| Children's National Hospital | Washington D.C., District of Columbia, United States | Recruiting |
| The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University | Baltimore, Maryland, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT05141058