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NCT05141058 · ClinicalTrials.gov registry record · Phase 1
T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients
A Phase 1 study of SARS CoV 2 Infection, sponsored by Children's National Research Institute.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 2
- Study locations
NCT05141058: Recruiting Phase 1 study of SARS CoV 2 Infection, sponsored by Children's National Research Institute.
NCT05141058 is a Phase 1 study of SARS CoV 2 Infection that is actively recruiting participants, run by Children's National Research Institute. The registered enrollment target is 24 participants, below the 4,187-participant average among 35 other SARS CoV 2 Infection trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05141058, a Phase 1 study of SARS CoV 2 Infection, is actively recruiting participants, sponsored by Children's National Research Institute.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
Number of patients with grade ≥3 infusion-related AEs at 45 days of following CST infusion.
Conditions Studied
Interventions
- BIOLOGICAL Coronavirus-specific T cell (CST)
Study Locations (2)
District of Columbia
- Children's National Hospital - Washington D.C.
Maryland
- The Sidney Kimmel Comprehensive Cancer Center, Johns Hopkins University - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2029-12-15 |
| Phase | Phase 1 |
What NCT05141058 shows while recruiting
NCT05141058 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 4,187-participant average among 35 other SARS CoV 2 Infection trials with a reported enrollment target (99% lower).
The record links to 1 condition, with SARS CoV 2 Infection appearing as the primary indexed condition, and to 1 intervention - of which Coronavirus-specific T cell (CST) is the first listed.
NCT05141058 reports a single indexed study location in District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT05141058 about?
NCT05141058 is a clinical study titled "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 pr...
What is the current status of trial NCT05141058?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2021-10-19. Estimated completion is 2029-12-15.
What conditions does trial NCT05141058 study?
This clinical trial studies the following conditions: SARS CoV 2 Infection.
What interventions are being tested in trial NCT05141058?
The interventions under investigation include: Coronavirus-specific T cell (CST) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05141058?
This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05141058 being conducted?
This trial has 2 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05141058's enrollment target sits among peer trials
24 35th of 35 higher than 1 of 35 other SARS CoV 2 Infection trials
participants (enrollment target), bucketed by value
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