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NCT04293042 · ClinicalTrials.gov registry record · Early Phase 1
Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients
A Early Phase 1 study of BK Polyomavirus, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT04293042: Recruiting Early Phase 1 study of BK Polyomavirus, sponsored by Children's Hospital of Philadelphia.
NCT04293042 is a Early Phase 1 study of BK Polyomavirus that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 20 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04293042, a Early Phase 1 study of BK Polyomavirus, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantation (HSCT), renal transplantation, and chemotherapy.
Primary Outcome
Number of participants with Grade III-IV acute GVHD as assessed by CTCAE v4.0
Conditions Studied
Interventions
- BIOLOGICAL BK-virus specific CTLs
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2019-10-07 |
| Est. Completion | 2028-12-30 |
| Phase | Early Phase 1 |
What NCT04293042 shows while recruiting
NCT04293042 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (62% lower).
The record links to 1 condition, with BK Polyomavirus appearing as the primary indexed condition, and to 1 intervention - of which BK-virus specific CTLs is the first listed.
NCT04293042 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT04293042 about?
NCT04293042 is a clinical study titled "Treatment of BK Virus Infection With CTL Cells in Immunocompromised Transplant Patients". This is a pilot study using cytotoxic T lymphocytes (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Gamma-capture system will be effective in decreasing specific viral load in patients with BK virus viremia and BK virus-associated symptoms post-allogeneic hematopoietic stem cell transplantat...
What is the current status of trial NCT04293042?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 20 participants. The study started on 2019-10-07. Estimated completion is 2028-12-30.
What conditions does trial NCT04293042 study?
This clinical trial studies the following conditions: BK Polyomavirus.
What interventions are being tested in trial NCT04293042?
The interventions under investigation include: BK-virus specific CTLs (BIOLOGICAL).
Who is sponsoring clinical trial NCT04293042?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04293042 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04293042's enrollment target sits among peer trials
20 1157th of 2000 higher than 710 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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