NCT00368082Active, not recruitingPhase 1
Autologous/Allogeneic TGFbeta-resistant LMP-specific CTL, Lymphoma (TGF-beta)
Administration of TGF-b Resistant LMP-Specific Cytotoxic T-Lymphocytes to Patients With Relapsed EBV-Positive Lymphoma
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Brief summary (registry, in English)
Patients have a type of lymph gland cancer called HD, NHL or lymphoepithelioma (these 3 diseases will be referred to as "Lymphoma"). The lymphoma has come back or has not gone away after treatment. This is a research study using special immune system cells called TGFb-resistant LMP-specific cytotoxic T lymphocytes (DNR-CTL), a new experimental therapy. Some patients with Lymphoma show signs of infection with the Epstein Barr virus (EBV) before or at the time of their Lymphoma diagnosis. EBV is found in the cancer cells of up to 1/2 the patients with Lymphoma, suggesting 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 by releasing a substance called Transforming Growth Factor-beta (TGFb). The investigators want to see if special white blood cells (called T cells) that have been given a gene that they hope will let them survive against TGFb and that have been trained to kill EBV infected cells can also survive in the blood and kill the tumor. Investigators have used this sort of therapy with specially trained T cells to treat a different type of cancer that occurs after bone marrow and solid organ transplant called post transplant lymphoma. In this type of cancer they were able to successfully prevent and treat post transplant lymphoma. However when they used a similar approach in HD some patients had a partial response to this therapy, but no patients had a complete response. In a follow-up study they tried to find out if they could improve this treatment by growing T cells that recognize 2 of the proteins expressed on Lymphoma cells called LMP-1 and LMP2a. These special T cells were called LMP-specific cytotoxic T-lymphocytes (CTLs). Although some patients had tumor responses, CTL therapy alone did not cure those who had a lot of disease. Investigators think that a reason for this is that the tumor cells are releasing TGFb. For this reason, they want to find out if they can make the CTL resistant to TGFb by putting in a new gene called TGFb resistance gene. Investigators hope that this will improve this treatment for relapsed lymphoma. These TGFb-resistant LMP-specific CTLs are an investigational product not approved by FDA. The purpose of this study is to find the largest safe dose of TGFb resistant LMP-specific CTLs, to learn what the side effects are and to see whether this therapy might help patients with Lymphoma.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 8 (actual)
- First submitted
- 22 Aug 2006
- Start date
- Apr 2006
- Primary completion date
- Sept 2013
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Hodgkin lymphoma, Childhood cancers
- NCT number
- NCT00368082
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 8
- From Apr 2006 to the primary completion date, Sept 2013
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Due to unknown effects of this therapy on a fetus, pregnant women are excluded from this research. The male partner should use a condom.
Other illness
- Patients with a severe intercurrent infection.
- HIV positive at time of procurement cells for CTL generation
Other
- Patients with evidence of GVHD greater than Grade II at time of enrollment.
Who the study is looking for
- Any patient, regardless of age or sex, with EBV-positive lymphoma, or lymphoepithelioma regardless of the histological subtype or EBV (associated)-T/NK-LPD all confirmed on any tissue sample.
- Primary refractory lymphoma or in second or subsequent relapse including after autologous or syngeneic stem cell transplant OR patients at a high risk for relapse defined as: (i) patients with primary refractory lymphoma or multiply relapsed lymphoma who are in remission but not eligible for autologous SCT or (ii) patients with relapsed lymphoma after autologous SCT who are in remission but not eligible for allogeneic SCT (Group A)
- OR
- Any patient who has received an allogeneic SCT for EBV Lymphoma or EBV (associated)-T/NK-LPD or Lymphoepithelioma (Group B)
- Patients with life expectancy 6 weeks or greater from the time of CTL infusion.
- Patients with a Karnofsky score of 50 or greater.
- If post allogeneic SCT must not have less than 50% donor chimerism in either peripheral blood or bone marrow
- Patients with bilirubin 3x normal or less, AST 5x normal or less, and Hgb greater than 8.0
- Patients with a creatinine 2x normal for age or less
- Patients with O2 saturations greater than 93% on room air (measured by pulse oximetry)
- Patient, parent/guardian able to give informed consent.
- Patients should have been off other investigational therapy for one month prior to entry in this study.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Houston Methodist Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Texas Childrens Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.