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NCT04197596 · ClinicalTrials.gov registry record · Phase 1
Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)
A Phase 1 study of Viral Infection and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 8
- Study locations
NCT04197596 is a Phase 1 study of Viral Infection and Primary Immune Deficiency Disorder that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 40 participants, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (82% lower). The trial reports 8 study locations across 8 states.
The verdict
NCT04197596, a Phase 1 study of Viral Infection and Primary Immune Deficiency Disorder, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 8
- Study locations
Study Summary
BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT) or with primary immunodeficiencies (PID).
Conditions Studied
Interventions
- BIOLOGICAL BK CTL
Study Locations (8)
California
- University of California San Francisco - San Francisco
Colorado
- Children's Hospital of Colorado - Aurora
Maryland
- Johns Hopkins - Baltimore
Missouri
- Washington University - St Louis
New York
- New York Medical College - Valhalla
Ohio
- Nationwide Children's Hosptial - Columbus
Pennsylvania
- Children's Hospital of Pennsylvania - Philadelphia
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-01 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04197596
The ClinicalTrials.gov registry entry for NCT04197596 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (82% lower). The listed sponsor is New York Medical College, which has 47 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Viral Infection appearing as the primary indexed condition, and to 1 intervention - of which BK CTL is the first listed.
NCT04197596 reports 8 study locations spanning 8 distinct geographic areas - top geographies include California, Colorado, Maryland.
Frequently Asked Questions
What is clinical trial NCT04197596 about?
NCT04197596 is a clinical study titled "Treatment of Refractory BK Infections With Related Donor BK Specific Cytotoxic T-cells (CTLs)". BK cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be safe and effective in decreasing specific viral load in children, adolescents and young adults (CAYA) with refractory BK infection post Allogeneic Hematopoietic Stem Cell Transplantation (All...
What is the current status of trial NCT04197596?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2020-07-01. Estimated completion is 2025-06-30.
What conditions does trial NCT04197596 study?
This clinical trial studies the following conditions: Viral Infection, Primary Immune Deficiency Disorder.
What interventions are being tested in trial NCT04197596?
The interventions under investigation include: BK CTL (BIOLOGICAL).
Who is sponsoring clinical trial NCT04197596?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04197596 being conducted?
This trial has 8 study locations across California, Colorado, Maryland, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.