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NCT03266653 · ClinicalTrials.gov registry record · Phase 2
EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection
A Phase 2 study of Epstein-Barr Virus Infections and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 8
- Study locations
NCT03266653: Recruiting Phase 2 study of Epstein-Barr Virus Infections and Primary Immune Deficiency Disorder, sponsored by New York Medical College.
NCT03266653 is a Phase 2 study of Epstein-Barr Virus Infections 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 246-participant average among 6 other Epstein-Barr Virus Infections trials with a reported enrollment target (92% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03266653, a Phase 2 study of Epstein-Barr Virus Infections 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
- 8
- Study locations
Study Summary
Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV 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 monitored for adverse events related to the infusion of EBV CTLs
Conditions Studied
Interventions
- DRUG cytotoxic t-lymphocytes
Study Locations (8)
California
- Children's Hosptial Los Angeles - Los Angeles
- University of California San Francisco - San Francisco
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/Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What NCT03266653 shows while recruiting
NCT03266653 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 246-participant average among 6 other Epstein-Barr Virus Infections trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Epstein-Barr Virus Infections appearing as the primary indexed condition, and to 1 intervention - of which cytotoxic t-lymphocytes is the first listed.
NCT03266653 lists 8 locations in 7 states (California, Maryland, Missouri).
Frequently Asked Questions
What is clinical trial NCT03266653 about?
NCT03266653 is a clinical study titled "EBV-specific Cytotoxic T-lymphocytes (CTLs) for Refractory EBV Infection". Related donor Epstein-Barr Virus (EBV) specific cytotoxic T cells (CTLs) manufactured with the Miltenyi CliniMACS Prodigy Cytokine Capture System will be administered in children, adolescents and young adults with refractory EBV infection post Allogeneic Hematopoietic Stem Cell Transplantation (Allo...
What is the current status of trial NCT03266653?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2020-07-07. Estimated completion is 2027-12-31.
What conditions does trial NCT03266653 study?
This clinical trial studies the following conditions: Epstein-Barr Virus Infections, Primary Immune Deficiency Disorder.
What interventions are being tested in trial NCT03266653?
The interventions under investigation include: cytotoxic t-lymphocytes (DRUG).
Who is sponsoring clinical trial NCT03266653?
This trial is sponsored by New York Medical College, which has 47 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03266653 being conducted?
This trial has 8 study locations across California, Maryland, Missouri, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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