T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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.

NCT Number	NCT05141058
Lead Sponsor	Children's National Research Institute
Conditions	SARS-CoV-2 Infection
Enrollment	24 participants
Start Date	2021-10-19
Primary Completion	2028-11-01 (estimated)
Study Completion	2029-12-15 (estimated)
Updated on ClinicalTrials.gov	2026-03-12