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NCT01923766 · ClinicalTrials.gov registry record · Phase 1

Cytotoxic T Cells to Prevent Virus Infections

A Phase 1 study of CMV and EBV, sponsored by Children's National Research Institute.

Completed
Registry status
Phase 1
Development phase
10
Enrollment target
2
Study locations

NCT01923766 is a Phase 1 study of CMV and EBV that has completed, run by Children's National Research Institute. The registered enrollment target is 10 participants, below the 361-participant average among 7 other CMV trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT01923766, a Phase 1 study of CMV and EBV, has completed, sponsored by Children's National Research Institute.

COMPLETED
Registry status
Phase 1
Development phase
10 participants
Enrollment target
2
Study locations

Study Summary

In this study, investigators are trying to see if infusion of "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant. Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord blood transplant (UCBT) from an unrelated donor. After receiving a cord blood transplant, they are at risk of infections until a new immune system to fight infections grows from the cord blood cells. In this study, investigators are trying to give special cells from the cord blood called T cells. These cells will try to fight viruses that can cause infection. Investigators will test to see if blood cells from donor that have been grown in a special way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can cause serious life-threatening infections in patients who have weak immune systems after transplant. T lymphocytes can kill viral cells but normally there are not enough of them to kill all the virus infected cells after transplant. Some researcher have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person during a viral infection after a bone marrow transplant. Some of these studies have shown a positive therapeutic effect in patients receiving the CTLs (specially trained T cells) after a viral infection in the post-transplant period. In this study we are trying to prevent or treat viral infections by given the CTLs soon after getting the umbilical cord blood transplant. With this study, investigators want to see if they can use a kind of white blood cell called T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells from the cord blood before transplant. These cells have been trained to attack adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer) T-cells or "m-CTL." Investigators would plan to

Interventions

  • DRUG Cytotoxic T lymphocytes (CTLs).

Study Locations (2)

District of Columbia

  • Childrens National Medical Center - Washington D.C.

Texas

  • Amanda Olson, MD - Houston

Trial Details

FieldValue
Enrollment Target 10 participants
Start Date 2013-09
Est. Completion 2020-03-25
Phase Phase 1

What the Registry Record Tells You About NCT01923766

The ClinicalTrials.gov registry entry for NCT01923766 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 361-participant average among 7 other CMV trials with a reported enrollment target (97% lower). The listed sponsor is Children's National Research Institute, which has 92 total studies on file at ClinicalTrials.gov.

The record links to 3 conditions, with CMV appearing as the primary indexed condition, and to 1 intervention - of which Cytotoxic T lymphocytes (CTLs). is the first listed.

NCT01923766 reports 2 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Texas.

Frequently Asked Questions

What is clinical trial NCT01923766 about?

NCT01923766 is a clinical study titled "Cytotoxic T Cells to Prevent Virus Infections". In this study, investigators are trying to see if infusion of "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant. Patients with blood cell cancer, other blood disease or a genetic disease may rece...

What is the current status of trial NCT01923766?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2013-09. Estimated completion is 2020-03-25.

What conditions does trial NCT01923766 study?

This clinical trial studies the following conditions: CMV, EBV, Adenovirus Infections.

What interventions are being tested in trial NCT01923766?

The interventions under investigation include: Cytotoxic T lymphocytes (CTLs). (DRUG).

Who is sponsoring clinical trial NCT01923766?

This trial is sponsored by Children's National Research Institute, which has 92 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01923766 being conducted?

This trial has 2 study locations across District of Columbia, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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