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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: Recruiting Phase 1 study of Viral Infection and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Patients will be monitored for adverse events following each CTL infusion
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 |
What NCT04197596 shows while recruiting
NCT04197596 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 225-participant average among 11 other Viral Infection trials with a reported enrollment target (82% lower).
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 lists 8 locations in 8 states (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.
Learn More About Clinical Trials
Similar trials for Viral Infection
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04197596's enrollment target sits among peer trials
40 10th of 11 higher than 2 of 11 other Viral Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Viral Infection 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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