EBV-positive Nasopharyngeal CarcinomaPhase 1NCT02065362
TGF-beta Resistant Cytotoxic T-lymphocytes in Treatment of EBV-positive Nasopharyngeal Carcinoma / RESIST-NPC
A Phase 1 study testing DNR.NPC-specific T cells and DNR.NPC-specific T cells + cyclophosphamide + fludarabine in people with EBV-positive Nasopharyngeal Carcinoma, run by Baylor College of Medicine at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- EBV-positive Nasopharyngeal Carcinoma
- What is being tested?
- DNR.NPC-specific T cells and DNR.NPC-specific T cells + cyclophosphamide + fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to Feb 2033
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 19Show fewer
- 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.
Who cannot join
- At time of Procurement:
- •Known HIV positivity
- At time of Treatment:
- Pregnant or lactating
- Severe intercurrent infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Administration Of TGF-beta Resistant Cytotoxic T-Lymphocytes to Patients With EBV-positive Nasopharyngeal Carcinoma (RESIST-NPC)
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.
Read more
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.
Read the detailed description
Blood will be collected from the patient to make LMP/BARF1/EBNA1 (NPC)-specific T cells. To grow NPC-specific T cells we have to use special cells called antigen-presenting cells, which train the patient's T cells to be NPC specific. Antigen presenting cells, so called monocytes or dendritic cells, will be grown/isolated from the patient's blood. In addition, we use a cell line called K562 as antigen-presenting cells that has had genes put inside it, which encourage the patient's T cells to grow. K562 cells are cancer cells. As such, if injected they could cause cancer. The cells have been treated with radiation so they cannot grow.
These antigen-presenting cells are coated with a specially produced mixture of LMP, EBNA1 and BARF protein fragments called peptides. These coated antigen-presenting cells are then used to generate the patient's NPC-specific T cells in the presence of growth factors. To get the DNR to attach to the surface of these NPC-specific T Cells, we also inserted the DNR gene into the NPC-specific T cells (DNR.NPC-specific T cells). This is done with a virus called a retrovirus that has been made for this study. This virus will carry the DNR gene into the cells.
Once we have made sufficient numbers of DNR.NPC-specific T cells we will freeze the cells and test them to make sure they recognize EBV proteins present in NPC.
Patients will get treated with 1) either two doses of DNR.NPC-specific T cells (the second dose will be given 2 weeks after the first dose) or 2)cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.
The cyclophosphamide and fludarabine will be given through a needle inserted into a vein or patient's port-a-cath).
The T cells will be thawed and infused through a central line, or through a vein in the patient's arm over 1 to 10 minutes. Patients will be followed in the clinic after the infusion for 1 to 4 hours.
All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
Medical tests before treatment:
Before being treated, the patient will receive a series of standard medical tests:
Physical exam Imaging Study Blood tests to measure blood cells, kidney and liver function Measurements of the tumor by routine imaging studies. We will use the imaging study that was used before to follow the patient's tumor: Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT)
Medical tests during and after treatment:
The patient will receive standard medical tests when they are getting the infusions and after:
Physical exams Blood tests to measure blood cells, kidney and liver function Imaging study 8 weeks after the 1st T-cell infusion(for patients receiving only DNR.NPC-specific T cells ) or Imaging study 6 weeks after the T-cell infusion (for patients receiving fludarabine and cyclophosphamide before DNR.NPC-specific T-cell infusion).
To learn more about the way the DNR.NPC-specific T cells are working and how long they last in the body, an extra 60ml or 3ml/kg of body weight of blood (whichever is less) will be taken pre-chemotherapy (for the patients receiving chemotherapy), on the day of the T-cell infusion (before and at the end of the T-cell infusion), 1, 2, 3, 4. 6, and 8 weeks( the last time point only for patients receiving DNR.NPC-specific T-cells only) after the T-cell infusion and every 3 months for 1 year, every 6 months for 4 years, then yearly for a total of 15 years. One additional blood sample might be drawn 3 to 4 days post the 1st T-cell infusion; this is optional. This volume is considered safe, but may be decreased if the patient is anemic. In addition to the blood tests, the patient will receive 2 imaging studies as stated above.
During the time points listed above, if the DNR.NPC-specific T cells are found in patient's blood at a certain amount an extra 5ml of blood may need to be collected for additional testing.
- Conditions
- EBV-positive Nasopharyngeal Carcinoma
- Being tested
- DNR.NPC-specific T cells, DNR.NPC-specific T cells + cyclophosphamide + fludarabine
- Keywords
- EBV positive, TGFbeta, Nasopharyngeal carcinoma, cytotoxic T lymphocytes
- Medical subject headings
- Camurati-Engelmann Syndrome, Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DNR.NPC-specific T cellsBiological
Each patient will receive 2 infusions, 14 days apart, according to the following dosing schedule:
Dose Level 1:
Day 0: 2 x 10^7 cells/m^2
Day 14: 2 x 10^7 cells/m^2
The doses are calculated according to the total T cell number.
DNR.NPC-specific T cells + cyclophosphamide + fludarabineBiological
Patients will receive cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.
Each patient will receive infusions according to the following dosing schedule:
Dose Level 2:
Cy/Flu on Days -4 to -2 and then 4 x 10^7 cells/m^2 on Day 0, Day 1 or Day 2
Dose Level 3:
Cy/Flu on Days -4 to -2 and then 1 x 10^8 cells/m^2 on Day 0, Day 1, or Day 2
| Study group | Role | What they receive |
|---|---|---|
| DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f | Experimental | DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f Receives: Biological: DNR.NPC-specific T cells; Biological: DNR.NPC-specific T cells + cyclophosphamide + fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with a dose limiting toxicity
Determine the safety of escalating doses of intravenous infusions of autologous TGFbeta-resistant NPC-specific cytotoxic T-lymphocytes with lymphodepleting chemotherapy for dose levels 2 and 3 in patients with EBV-positive nasopharyngeal carcinoma (NPC).
Measured: 8 weeks
Secondary outcomes (1)
Amount of T cells in the blood after the infusions
Determine the survival and the immune function of TGFbeta-resistant NPC specific T cells.
Measured: 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startFeb 2015
- Primary completionMar 2017
- Study completionFeb 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EBV-positive Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen Heslop, MD, Principal investigator, Baylor College of Medicine/Texas Children's Hospital /Houston Methodist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065362
- Sponsor's protocol ID
- H-33954: RESIST-NPC
- Other IDs
- P01CA094237
- Status last verified
- Jan 2026
- First submitted
- 14 Feb 2014
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration Of TGF-beta Resistant Cytotoxic T-Lymphocytes to Patients With EBV-positive Nasopharyngeal Carcinoma (RESIST-NPC)
- ClinicalTrials.gov ID
- NCT02065362
- Acronym / sponsor ID
- H-33954: RESIST-NPC
- Conditions
- EBV-positive Nasopharyngeal Carcinoma
- Keywords
- EBV positive, TGFbeta, Nasopharyngeal carcinoma, cytotoxic T lymphocytes
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute
- Study start
- Feb 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Feb 2033 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Blood will be collected from the patient to make LMP/BARF1/EBNA1 (NPC)-specific T cells. To grow NPC-specific T cells we have to use special cells called antigen-presenting cells, which train the patient's T cells to be NPC specific. Antigen presenting cells, so called monocytes or dendritic cells, will be grown/isolated from the patient's blood. In addition, we use a cell line called K562 as antigen-presenting cells that has had genes put inside it, which encourage the patient's T cells to grow. K562 cells are cancer cells. As such, if injected they could cause cancer. The cells have been treated with radiation so they cannot grow.
These antigen-presenting cells are coated with a specially produced mixture of LMP, EBNA1 and BARF protein fragments called peptides. These coated antigen-presenting cells are then used to generate the patient's NPC-specific T cells in the presence of growth factors. To get the DNR to attach to the surface of these NPC-specific T Cells, we also inserted the DNR gene into the NPC-specific T cells (DNR.NPC-specific T cells). This is done with a virus called a retrovirus that has been made for this study. This virus will carry the DNR gene into the cells.
Once we have made sufficient numbers of DNR.NPC-specific T cells we will freeze the cells and test them to make sure they recognize EBV proteins present in NPC.
Patients will get treated with 1) either two doses of DNR.NPC-specific T cells (the second dose will be given 2 weeks after the first dose) or 2)cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.
The cyclophosphamide and fludarabine will be given through a needle inserted into a vein or patient's port-a-cath).
The T cells will be thawed and infused through a central line, or through a vein in the patient's arm over 1 to 10 minutes. Patients will be followed in the clinic after the infusion for 1 to 4 hours.
All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
Medical tests before treatment:
Before being treated, the patient will receive a series of standard medical tests:
Physical exam Imaging Study Blood tests to measure blood cells, kidney and liver function Measurements of the tumor by routine imaging studies. We will use the imaging study that was used before to follow the patient's tumor: Computer Tomogram (CT), Magnetic Resonance Imaging (MRI), or Positron Emission Tomography (PET/CT)
Medical tests during and after treatment:
The patient will receive standard medical tests when they are getting the infusions and after:
Physical exams Blood tests to measure blood cells, kidney and liver function Imaging study 8 weeks after the 1st T-cell infusion(for patients receiving only DNR.NPC-specific T cells ) or Imaging study 6 weeks after the T-cell infusion (for patients receiving fludarabine and cyclophosphamide before DNR.NPC-specific T-cell infusion).
To learn more about the way the DNR.NPC-specific T cells are working and how long they last in the body, an extra 60ml or 3ml/kg of body weight of blood (whichever is less) will be taken pre-chemotherapy (for the patients receiving chemotherapy), on the day of the T-cell infusion (before and at the end of the T-cell infusion), 1, 2, 3, 4. 6, and 8 weeks( the last time point only for patients receiving DNR.NPC-specific T-cells only) after the T-cell infusion and every 3 months for 1 year, every 6 months for 4 years, then yearly for a total of 15 years. One additional blood sample might be drawn 3 to 4 days post the 1st T-cell infusion; this is optional. This volume is considered safe, but may be decreased if the patient is anemic. In addition to the blood tests, the patient will receive 2 imaging studies as stated above.
During the time points listed above, if the DNR.NPC-specific T cells are found in patient's blood at a certain amount an extra 5ml of blood may need to be collected for additional testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f | Experimental | Biological: DNR.NPC-specific T cells, Biological: DNR.NPC-specific T cells + cyclophosphamide + fludarabineDNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (19 listed)
- 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
- Nasopharyngeal Carcinoma in first or subsequent relapse or with primary refractory disease
Key exclusion criteria (5 listed)
- •Known HIV positivity
- Pregnant or lactating
- Severe intercurrent infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DNR.NPC-specific T cellsEach patient will receive 2 infusions, 14 days apart, according to the following dosing schedule: Dose Level 1: Day 0: 2 x 10^7 cells/m^2 Day 14: 2 x 10^7 cells/m^2 The doses are calculated according to the total T cell number. | Biological | DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f |
| DNR.NPC-specific T cells + cyclophosphamide + fludarabinePatients will receive cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells. Each patient will receive infusions according to the following dosing schedule: Dose Level 2: Cy/Flu on Days -4 to -2 and then 4 x 10^7 cells/m^2 on Day 0, Day 1 or Day 2 Dose Level 3: Cy/Flu on Days -4 to -2 and then 1 x 10^8 cells/m^2 on Day 0, Day 1, or Day 2 | Biological | DNR.NPC-specific T cells or DNR.NPC-specific T cells + c/f |
Primary outcome
Number of subjects with a dose limiting toxicity
Time frame: 8 weeks
Determine the safety of escalating doses of intravenous infusions of autologous TGFbeta-resistant NPC-specific cytotoxic T-lymphocytes with lymphodepleting chemotherapy for dose levels 2 and 3 in patients with EBV-positive nasopharyngeal carcinoma (NPC).
1 secondary outcome
Amount of T cells in the blood after the infusions
Time frame: 15 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Heslop, MD principal investigator
Baylor College of Medicine/Texas Children's Hospital /Houston Methodist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DNR.NPC-specific T cells and DNR.NPC-specific T cells + cyclophosphamide + fludarabine in people with EBV-positive Nasopharyngeal Carcinoma, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with a dose limiting toxicity (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.