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NCT01333046 · ClinicalTrials.gov registry record · Phase 1
Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL
A Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Lymphoma, sponsored by Baylor College of Medicine.
- Active
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 2
- Study locations
NCT01333046 is a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Lymphoma that is active but no longer recruiting, run by Baylor College of Medicine. The registered enrollment target is 36 participants, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (76% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT01333046, a Phase 1 study of Non-Hodgkin Lymphoma and Hodgkin Lymphoma, is active but no longer recruiting, sponsored by Baylor College of Medicine.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy. This sort of therapy has been used previously to treat Hodgkin or non-Hodgkin lymphomas that show proof of infection with Epstein-Barr virus (EBV), the virus that causes infectious mononucleosis ("mono" or the "kissing disease"). EBV is found in cancer cells of up to half of all patients with Hodgkin's and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. Investigators tested whether special white blood cells, called T cells, that were trained to kill EBV-infected cells could affect these tumors, and in many patients it was found that giving these trained T cells caused a complete or partial response. However, many patients do not have EBV in their lymphoma cells; therefore investigators now want to test whether it is possible to direct these special T cells against other types of proteins on the tumor cell surface with similar promising results. The proteins that will be targeted in this study are called tumor associated antigens (TAAs) - these are cell proteins that are specific to the cancer cell, so they either do not show or show up in low quantities on normal human cells. In this study, we will target five TAAs which commonly show on lymphoma, called: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX. This will be done by using special types of T cells called cytotoxic T lymphocytes (CTLs) generated in the lab. In addition, some adult patients will receive a drug called azacytidine before giving the T cells. We hope that the combination helps the T cells work bet
Conditions Studied
Interventions
- BIOLOGICAL Antigen-Escalation Stage
- BIOLOGICAL Dose-Escalation Stage
- BIOLOGICAL azacytidine and multiTAA T cells Stage
- BIOLOGICAL Pediatric multiTAA T cells Stage
Study Locations (2)
Texas
- Houston Methodist Hospital - Houston
- Texas Children's Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-01 |
| Est. Completion | 2027-09-27 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01333046
The ClinicalTrials.gov registry entry for NCT01333046 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 151-participant average among 104 other Non-Hodgkin Lymphoma trials with a reported enrollment target (76% lower). The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Non-Hodgkin Lymphoma appearing as the primary indexed condition, and to 4 interventions - of which Antigen-Escalation Stage is the first listed.
NCT01333046 reports 2 study locations spanning 1 distinct geographic area - top geographies include Texas.
Frequently Asked Questions
What is clinical trial NCT01333046 about?
NCT01333046 is a clinical study titled "Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL". Patients have a type of lymph gland disease called Hodgkin or non-Hodgkin lymphoma which has come back, or may come back, or has not gone away after treatment, including the standard treatment known for these diseases. This a research study using special immune system cells called tumor associated a...
What is the current status of trial NCT01333046?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2012-01. Estimated completion is 2027-09-27.
What conditions does trial NCT01333046 study?
This clinical trial studies the following conditions: Non-Hodgkin Lymphoma, Hodgkin Lymphoma, Hodgkin Disease.
What interventions are being tested in trial NCT01333046?
The interventions under investigation include: Antigen-Escalation Stage (BIOLOGICAL), Dose-Escalation Stage (BIOLOGICAL), azacytidine and multiTAA T cells Stage (BIOLOGICAL), Pediatric multiTAA T cells Stage (BIOLOGICAL).
Who is sponsoring clinical trial NCT01333046?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01333046 being conducted?
This trial has 2 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.