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NCT01205334 · ClinicalTrials.gov registry record · Phase 1

Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme

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

Terminated
Registry status
Phase 1
Development phase
2
Enrollment target

NCT01205334: Clinical Trial Phase 1 study, sponsored by Baylor College of Medicine.

NCT01205334 is a Phase 1 study that was terminated before completion, run by Baylor College of Medicine. The registered enrollment target is 2 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01205334, a Phase 1 study, was terminated before completion, sponsored by Baylor College of Medicine.

TERMINATED
Registry status
Phase 1
Development phase
2 participants
Enrollment target

Study Summary

Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come back after standard therapy, patients are being asked to volunteer to take part in a research study using special immune cells. They may have already thought about being in this study. Some patients with GBM show evidence of infection with a virus called Cytomegalovirus before the time of their diagnosis. CMV is found in the cancer cells of some patients with GBM, suggesting that it may play a role in causing the disease. The cancer cells infected by CMV 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 recognize and kill special parts of CMV infected cells can survive in the blood and affect the tumor. We have used this sort of therapy to treat different types of cancer that are positive for other viruses and have had variable results. Some patients have had responses others did not. It is not possible for us to predict if this treatment will work for GBM. The purpose of this study is to find the largest safe dose of CMV-T cells, to learn what the side effects are, and to see whether this therapy might help patients with GBM.

Primary Outcome

The main aim will be to collect information about the maximum tolerated dosage to evaluate the safety of escalating doses of autologous CMV-specific cytotoxic T-lymphocytes (CTL) in patients with CMV-positive Glioblastoma multiforme (GBM)

Interventions

  • BIOLOGICAL Autologous CMV-specific CTL

Trial Details

FieldValue
Enrollment Target 2 participants
Start Date 2010-11
Est. Completion 2012-03
Phase Phase 1
Baylor College of Medicine

616 total trials

Why NCT01205334 stopped before completion

NCT01205334 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Autologous CMV-specific CTL is the first listed.

NCT01205334 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01205334 about?

NCT01205334 is a clinical study titled "Administration of CMV-Specific Cytotoxic T Cells in Patients With Glioblastoma Multiforme". Patients have a type of brain cancer called glioblastoma multiforme. Because most GBMs come back after standard therapy, patients are being asked to volunteer to take part in a research study using special immune cells. They may have already thought about being in this study. Some patients with GBM...

What is the current status of trial NCT01205334?

This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2010-11. Estimated completion is 2012-03.

What interventions are being tested in trial NCT01205334?

The interventions under investigation include: Autologous CMV-specific CTL (BIOLOGICAL).

Who is sponsoring clinical trial NCT01205334?

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 NCT01205334's enrollment target sits among peer trials

2 2000th of 2000 the lowest 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 NCT01205334, the US trial registry maintained by the National Library of Medicine. NCT01205334 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.