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NCT01447056 · ClinicalTrials.gov registry record · Phase 1

Most Closely HLA-Matched CTLs for Relapsed Epstein Barr Virus(EBV)-Associated Diseases

A Phase 1 study, sponsored by Baylor College of Medicine.

Completed
Registry status
Phase 1
Development phase
37
Enrollment target

NCT01447056: Completed Phase 1 study, sponsored by Baylor College of Medicine.

NCT01447056 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01447056, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.

COMPLETED
Registry status
Phase 1
Development phase
37 participants
Enrollment target

Study Summary

Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The disease has come back, may come back or has not gone away after treatment. This voluntary research study uses special immune system cells called LMP-specific cytotoxic T lymphocytes, a new experimental therapy. Some patients with these diseases show evidence of infection with the virus that causes infectious mononucleosis (called Epstein-Barr virus, or EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of up to half of the patients with lymphomas, and in some cases of NPC and LMS, suggesting that it may play a role in causing these diseases. Those cancer cells (as well as some B cells in SCAEBV) that are infected by EBV are able to hide from the body's immune system and escape destruction. We want to see if special white blood cells, called T cells, that have been trained to kill cells infected by EBV can survive in the blood and affect the tumor. This treatment with specially trained T cells has had activity against these viruses when the cells are made from patients with those diseases (or, after bone marrow transplant, from the patient's transplant donor). However, sometimes it is not possible to grow these cells; other times, it may take 2 to 3 months to make the cells, which may be too long when one has an active tumor. We are therefore asking if subjects would like to participate in this study, which tests if blood cells from a donor that is a partial match with the subject (or the transplant donor) that have been grown in the way described above can survive in the blood and affect the disease. These LMP-specific CTLs are an investigational product not approved by the Food and Drug Administration.

Primary Outcome

To determine the safety of intravenous injections of third-party, partially HLA- matched, allogeneic Epstein Barr Virus (EBV)-specific cytotoxic T-lymphocytes (CTL) in patients with severe chronic active EBV (SCAEBV) infection or EBV-associated Hodgkin or non-Hodgkin lymphomas (HL/NHL), other lymphoproliferative disorders (LPD) or other malignancies (leiomyosarcoma and nasopharyngeal carcinoma)

Interventions

  • BIOLOGICAL LMP specific T cells

Trial Details

FieldValue
Enrollment Target 37 participants
Start Date 2012-02
Est. Completion 2020-01-22
Phase Phase 1
Baylor College of Medicine

616 total trials

What the finished NCT01447056 record still lists

NCT01447056 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).

The record links to 0 conditions, and to 1 intervention - of which LMP specific T cells is the first listed.

NCT01447056 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01447056 about?

NCT01447056 is a clinical study titled "Most Closely HLA-Matched CTLs for Relapsed Epstein Barr Virus(EBV)-Associated Diseases". Patients have a type of a lymph node cancer called lymphoma, a tumor of the nasal passages called nasopharyngeal carcinoma (NPC), a tumor of a particular type of muscle called leiomyosarcoma (LMS) or a condition called severe chronic active EBV (SCAEBV) syndrome. The disease has come back, may come ...

What is the current status of trial NCT01447056?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2012-02. Estimated completion is 2020-01-22.

What interventions are being tested in trial NCT01447056?

The interventions under investigation include: LMP specific T cells (BIOLOGICAL).

Who is sponsoring clinical trial NCT01447056?

This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01447056's enrollment target sits among peer trials

37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT01447056, the US trial registry maintained by the National Library of Medicine. NCT01447056 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.