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NCT04722029 · ClinicalTrials.gov registry record · Phase 1
Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections
A Phase 1 study of Adenovirus Infection, sponsored by Nationwide Children's Hospital.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT04722029: Recruiting Phase 1 study of Adenovirus Infection, sponsored by Nationwide Children's Hospital.
NCT04722029 is a Phase 1 study of Adenovirus Infection that is actively recruiting participants, run by Nationwide Children's Hospital. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722029, a Phase 1 study of Adenovirus Infection, is actively recruiting participants, sponsored by Nationwide Children's Hospital.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the CliniMACS Cytokine Capture System (IFN-γ) after incubation with MACS GMP PepTivator Peptide Pools of Hexon 5 for enrichment.
Primary Outcome
Safety will be assess at 28 days post ADV-VSTS infusion. Safety is defined as presentation of unacceptable toxicities, measured by grade III-IV acute GVHD within 28 days, solid organ rejection/ graft failure within 28 days, grade \>4 infusional toxicity within 7 days of infusion, and grade 4-5 adverse events within 28 days per CTCAE 5.0.
Conditions Studied
Interventions
- BIOLOGICAL Adenovirus Specific T lymphocytes
Study Locations (1)
Ohio
- Nationwide Children's Hospital - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-10-01 |
| Est. Completion | 2027-10-01 |
| Phase | Phase 1 |
What NCT04722029 shows while recruiting
NCT04722029 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Adenovirus Infection appearing as the primary indexed condition, and to 1 intervention - of which Adenovirus Specific T lymphocytes is the first listed.
NCT04722029 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04722029 about?
NCT04722029 is a clinical study titled "Pilot Study of Haploidentical Donor Adenovirus Specific T-lymphocytes to Treat Refractory Adenovirus Infections". This open-label, single-arm, phase I/II clinical trial will assess the safety and efficacy of related donor adenovirus-specific T lymphocytes isolated from whole blood or leukapheresis products. The adenovirus-specific T lymphocytes will be generated automatically by the CliniMACS Prodigy using the ...
What is the current status of trial NCT04722029?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2021-10-01. Estimated completion is 2027-10-01.
What conditions does trial NCT04722029 study?
This clinical trial studies the following conditions: Adenovirus Infection.
What interventions are being tested in trial NCT04722029?
The interventions under investigation include: Adenovirus Specific T lymphocytes (BIOLOGICAL).
Who is sponsoring clinical trial NCT04722029?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04722029 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04722029's enrollment target sits among peer trials
12 1853rd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
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