NCT02065362Active, not recruitingPhase 1
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC
Administration Of TGF-beta Resistant Cytotoxic T-Lymphocytes to Patients With EBV-positive Nasopharyngeal Carcinoma (RESIST-NPC)
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
Patients have nasopharyngeal carcinoma (NPC). This study is a gene transfer research study using special immune cells. Most patients with NPC show evidence of infection with the virus that causes infectious mononucleosis Epstein Barr virus (EBV) before or at the time of their diagnosis. EBV is found in the cancer cells of almost all patients with advanced stage NPC, suggesting that it may play a role in causing the disease. The cancer cells 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 recognize and kill special parts of EBV infected cells can survive in patient's blood and affect the tumor. We already have given EBV-specific cytotoxic T cells to 30 patients with active NPC and have seen anti-tumor activity in 14 of 30 patients. We are now trying to find out if we can improve this treatment. First, we want to give T cells where more of the cells recognize at least two of the four EBV proteins expressed on NPC cells. We call these cells NPC-specific cytotoxic T cells. Second, we found that T cells work better if we add a receptor to the T cells called DNR (Dominant Negative Receptor). DNR makes T cells resistant to TGFbeta, a factor secreted by cancer cells that helps them escape being killed by the immune system. In this study we will therefore place the DNR gene into NPC-specific T cells (DNR.NPC-specific T cells). In other clinical studies using T cells, some investigators found that giving chemotherapy before the T cell infusion can improve the amount of time the T cells stay in the body and therefore the effect the T cells can have. Giving chemotherapy before a T cell infusion is called lymphodepletion since the chemotherapy is specifically chosen to decrease the number of lymphocytes in the body. Decreasing the number of patient's lymphocytes first should allow the T cells we infuse to expand and stay longer in their body, and potentially kill cancer cells more effectively. The chemotherapy we will use for lymphodepletion is a combination of cyclophosphamide and fludarabine. Cyclophosphamide and fludarabine are the chemotherapy agents most commonly used for lymphodepletion in immunotherapy clinical trials.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 14 (estimated)
- First submitted
- 14 Feb 2014
- Start date
- 1 Feb 2015
- Primary completion date
- 31 Mar 2017
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT02065362
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 14
- From 1 Feb 2015 to the primary completion date, 31 Mar 2017
- 1 site 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, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- •Known HIV positivity
- Severe intercurrent infection
Other
- At time of Procurement:
- At time of Treatment:
- Pregnant or lactating
Who the study is looking for
- The patient must meet the following eligibility inclusion criteria at the time of PROCUREMENT:
- Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease
- EBV positive tumor
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
- The patient must meet the following eligibility criteria to be included for TREATMENT:
- Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease
- EBV positive tumor
- Patients with life expectancy greater than or equal to 6 weeks
- Bilirubin less than or equal to 3x upper limit of normal
- AST less than or equal to 5x upper limit of normal
- ANC\>750/microliter
- Platelets \> 50,000/microliter
- Hgb ≥ 7.0g/dl (can be transfused)
- Creatinine less than or equal to 2x upper limit of normal for age, Creatinine clearance (as estimated by Cockcroft Gault or Schwartz) greater than or equal to 60 ml/min
- Pulse oximetry of \> 90% on room air
- Off investigational therapy for 4 weeks prior to study entry
- Karnofsky or Lansky score of greater than or equal to 50%
- Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's 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.