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NCT03475212 · ClinicalTrials.gov registry record · Phase 1
Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation
A Phase 1 study of Cytomegalovirus Infections and Adenovirus Infection, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
- Active
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 20
- Study locations
NCT03475212: Active Phase 1 study of Cytomegalovirus Infections and Adenovirus Infection, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
NCT03475212 is a Phase 1 study of Cytomegalovirus Infections and Adenovirus Infection that is active but no longer recruiting, run by Pediatric Transplantation & Cellular Therapy Consortium. The registered enrollment target is 52 participants, below the 200-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03475212, a Phase 1 study of Cytomegalovirus Infections and Adenovirus Infection, is active but no longer recruiting, sponsored by Pediatric Transplantation & Cellular Therapy Consortium.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell transplant.
Primary Outcome
Feasibility will be defined as the ability of the investigators to identify suitable partially HLA- matched VST products from the VST bank at Children's National Medical Center for referred study subjects. The percentage of referred patients with potential partially-matched VST products identified will be recorded, as will timing between patient referral and treatment.
Conditions Studied
Interventions
- BIOLOGICAL Virus Specific T-cell (VST) infusion
Study Locations (20)
California
- City of Hope - Duarte
- University of California, Los Angeles - Los Angeles
- Children's Hospital Los Angeles - Los Angeles
- Stanford Lucile Packard Children's Hospital - Palo Alto
- UCSF Medical Center - San Francisco
Massachusetts
- Tufts Medical Center - Boston
- Dana-Farber Cancer Institute/ Boston Children's Hospital - Boston
Michigan
- University of Michigan - Ann Arbor
- Spectrum Health - Helen DeVos Children's Hospital - Grand Rapids
New York
- Roswell Park Comprehensive Cancer Center - Buffalo
- Columbia University Medical Center - New York
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital Colorado - Aurora
Connecticut
- Yale - New Haven
District of Columbia
- Children's National Medical Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2018-06-20 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03475212 still lists
NCT03475212 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 200-participant average among 24 other Cytomegalovirus Infections trials with a reported enrollment target (74% lower).
The record links to 3 conditions, with Cytomegalovirus Infections appearing as the primary indexed condition, and to 1 intervention - of which Virus Specific T-cell (VST) infusion is the first listed.
NCT03475212 names 20 study sites across 13 states, led by California, Massachusetts, Michigan.
Frequently Asked Questions
What is clinical trial NCT03475212 about?
NCT03475212 is a clinical study titled "Antiviral Cellular Therapy for Enhancing T-cell Reconstitution Before or After Hematopoietic Stem Cell Transplantation". The purpose of this study is to evaluate whether virus-specific T cell lines (VSTs) are safe and can effectively control three viruses (EBV, CMV, and adenovirus) in patients who have had a stem cell transplant and also in patients that have a primary immunodeficiency disorder with no prior stem cell...
What is the current status of trial NCT03475212?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2018-06-20. Estimated completion is 2025-06-30.
What conditions does trial NCT03475212 study?
This clinical trial studies the following conditions: Cytomegalovirus Infections, Adenovirus Infection, EBV Infection.
What interventions are being tested in trial NCT03475212?
The interventions under investigation include: Virus Specific T-cell (VST) infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT03475212?
This trial is sponsored by Pediatric Transplantation & Cellular Therapy Consortium, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03475212 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03475212's enrollment target sits among peer trials
52 14th of 24 higher than 11 of 24 other Cytomegalovirus Infections trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cytomegalovirus Infections trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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