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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.

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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).

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

FieldValue
Enrollment Target 40 participants
Start Date 2020-07-01
Est. Completion 2025-06-30
Phase Phase 1

Sponsor

New York Medical College

47 total trials

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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