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NCT03266627 · ClinicalTrials.gov registry record · Phase 2
Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection
A Phase 2 study of Adenovirus and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 10
- Study locations
NCT03266627: Recruiting Phase 2 study of Adenovirus and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
NCT03266627 is a Phase 2 study of Adenovirus and Primary Immune Deficiency Disorder that is actively recruiting participants, run by New York Medical College. The registered enrollment target is 20 participants, below the 28-participant average among 6 other Adenovirus trials with a reported enrollment target (29% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266627, a Phase 2 study of Adenovirus and Primary Immune Deficiency Disorder, is actively recruiting participants, sponsored by New York Medical College.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 10
- Study locations
Study Summary
Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantation (AlloHSCT), with primary immunodeficiencies (PID) or post solid organ transplant. Funding Source: FDA OOPD
Primary Outcome
Patients will be followed for adverse events following each infusion of ADV CTLs
Conditions Studied
Interventions
- DRUG cytotoxic t-lymphocytes
Study Locations (10)
California
- Children's Hospital Los Angeles - Los Angeles
- University of California San Francisco - San Francisco
Colorado
- Children's Hospital of Colorado - Aurora
- University of Colorado Denver - Aurora
Indiana
- Indiana University - Indianapolis
Maryland
- Johns Hopkins - Baltimore
Missouri
- Washington University - St Louis
Ohio
- Nationwide Children's Hosptial - Columbus
Pennsylvania
- Children's Hospital of Pennsylvania - Philadelphia
Wisconsin
- Medical College of Wisconsin/Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2018-11-01 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03266627 shows while recruiting
NCT03266627 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 28-participant average among 6 other Adenovirus trials with a reported enrollment target (29% lower).
The record links to 2 conditions, with Adenovirus appearing as the primary indexed condition, and to 1 intervention - of which cytotoxic t-lymphocytes is the first listed.
NCT03266627 lists 10 locations in 8 states (California, Colorado, Indiana).
Frequently Asked Questions
What is clinical trial NCT03266627 about?
NCT03266627 is a clinical study titled "Adenovirus-specific Cytotoxic T-lymphocytes for Refractory Adenovirus Infection". Related donor Adenovirus (ADV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered intravenously in in children, adolescents and young adults with refractory ADV infection post Allogeneic Hematopoietic Stem Cell Transplantat...
What is the current status of trial NCT03266627?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2018-11-01. Estimated completion is 2027-12-31.
What conditions does trial NCT03266627 study?
This clinical trial studies the following conditions: Adenovirus, Primary Immune Deficiency Disorder.
What interventions are being tested in trial NCT03266627?
The interventions under investigation include: cytotoxic t-lymphocytes (DRUG).
Who is sponsoring clinical trial NCT03266627?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03266627 being conducted?
This trial has 10 study locations across California, Colorado, Indiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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