Hodgkin's DiseasePhase 1GRALENCT01555892
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
A Phase 1 study testing EBV-specific T cells: A and EBV-specific T cells: B in people with Hodgkin's Disease and Non-Hodgkin's Lymphoma, run by Baylor College of Medicine at 3 sites in United States.
Trial summary
Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hodgkin's Disease, Non-Hodgkin's Lymphoma, Lymphoproliferative Disease
- What is being tested?
- EBV-specific T cells: A and EBV-specific T cells: B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 3 sitesUnited States
- Study dates
- 14 Jan 2013to 1 Jul 2027
- 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
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component
- EBV positive tumor (can be pending at this time)
- Weighs at least 12kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)* and
- In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse) OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A)
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- OR
- In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B)
- EBV positive tumor
- Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value).
- Patients with a creatinine less than or equal to 2x upper limit of normal for age
- Pulse oximetry of > 90% on room air
- Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1/PDL inhibitors will be allowed if medically indicated.
- Patients with a Karnofsky/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.
- Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent.
- CAEBV is defined as patients with high EBV viral load in plasma or PBMC (> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
- Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.
Who cannot join
- 1. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)
- Pregnant or lactating
- Severe intercurrent infection.
- Current use of systemic corticosteroids > 0.5 mg/kg/day
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Not yet recruiting
Harris Health System (includes ben Taub General Hospital and Smith)
Houston, Texas, 77030
Martha Mims, MD, 713-444-7505, mmims@bcm.edu
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Helen E Heslop, MD, 832-824-4662, hheslop@bcm.edu
Vicky Torrano, 832-824-7821, vxtorran@txch.org
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
Helen E Heslop, MD, 832-824-4662, hheslop@bcm.edu
Vicky Torrano, 832-824-7821, vxtorran@txch.org
About this study
Official title: Administration of Rapidly Generated EBV-Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Lymphoma
Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases.
Some of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called GRALE T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor.
Read more
Investigators have used this sort of therapy to treat a different type of cancer called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. Investigators grew T cells in the lab that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor cells and B cells only express 4 EBV proteins. In a previous study, the investigators made T cells that recognized all 9 proteins and gave them to patients with HD. Some patients had a partial response to this therapy but no patients had a complete response. The investigators then did follow up studies where investigators made T cells that recognized the 2 EBV proteins seen in patients with lymphoma, T/NK-lymphoproliferative disease and CAEBV. Investigators have treated over 50 people on those studies. About 60% of those patients who had disease at the time they got the cells had responses including some patients with complete responses. This study will expand on those results and the investigators will try and make the T cells in the lab in a simpler faster way. These cells are called GRALE T cells. These GRALE T cells are an investigational product not approved by the FDA.
The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T cells created using this new manufacturing technique. Investigators will learn what the side effects are and to see whether this therapy might help patients with HD or NHL or EBV associated T/NK-lymphoproliferative disease or CAEBV.
Read the detailed description
Subjects (or their syngeneic donor) will give blood for investigators to make EBV-specific (GRALE) T cells in the lab. These cells will be grown and frozen for the subject.
In this study, patients may also receive cyclophosphamide and fludarabine. These two drugs are standard chemotherapy medicines and may be given before the T cells to make space in the blood for the T cells to grow after receiving them. These drugs will be given intravenously daily over three days.
The GRALE T cells will then be thawed and injected into the subject over 1-10 minutes. Initially, two doses of GRALE T cells will be given 2 weeks apart.
If after the 2nd infusion there is a demonstrated partial response or stable disease in the size of the lymphoma on CT or MRI scan as assessed by a radiologist, the subject can receive additional doses of the GRALE T cells if they wish (up to 6 times). Follow up testing will be collected just like after the 1st infusion.
All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
Investigators will follow the subjects after the injections. They will either be seen in the clinic or the subject will be contacted by a research nurse yearly for 5 years.
If they receive additional doses of the GRALE T cells as described above, they will be followed until 5 years after the last dose of GRALE T-cells.
For patients who receive more than one infusion, follow up will continue every 3 months until 12 months after the last infusion, then yearly thereafter for 5 years.
- Being tested
- EBV-specific T cells: A, EBV-specific T cells: B
- Keywords
- EBV, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma Relapse, Autologous or Syngeneic Stem Cell Transplant, T/NK-lymphoproliferative disease, LMP, BARF1, EBNA1
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin, Lymphoproliferative Disorders, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EBV-specific T cells: ABiological
Also called LMP, BARF1 and EBNA1 specific CTLs
Patients may receive cells with or without lymphodepletion. Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2
EBV-specific T cells: BBiological
Patients may receive cells with or without lymphodepletion. Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2
| Study group | Role | What they receive |
|---|---|---|
| EBV-specific T cells: A | Experimental | Group A: Patients in second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiple relapsed patients in remission who are at a high risk of relapse)** or any patient with primary disease or in first or subsequent remission if immunosuppressive chemotherapy is contraindicated.
Patients may receive cells with or without lymphodepletion.
Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule:
Day 0: 1 x 10^8 cells/m2
Day 14: 2 x 10^8 cells/m2
** Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant. Receives: Biological: EBV-specific T cells: A |
| EBV-specific T cells: B | Experimental | Group B: Patients in remission or with minimal residual disease (MRD) status after autologous or syngeneic SCT.
Patients may receive cells with or without lymphodepletion.
Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule:
Day 0: 1 x 10^8 cells/m2
Day 14: 2 x 10^8 cells/m2 Receives: Biological: EBV-specific T cells: B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 T lymphocytes
To determine the safety of escalating doses of 2 intravenous injections of autologous or syngeneic rapid LMP, BARF1 and EBNA1 specific T-lymphocytes (VSTs) in patients with EBV-associated Hodgkin's Disease or non-Hodgkin's lymphoma or T/NK-lymphoproliferative disease and CAEBV.
Measured: 8 weeks
Secondary outcomes (2)
Determine survival and immune function of LMP/BARF1/EBNA1-specific cytotoxic T-lymphocyte lines
To determine the survival and the immune function of LMP/BARF1/EBNA1-specific cytotoxic T-lymphocyte lines
Measured: 1 year
Assess anti-viral and anti-tumor effects of LMP/BARF1/EBNA1-specific EBVST
To assess the anti-viral and anti-tumor effects of LMP/BARF1/EBNA1-specific EBVST
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study start14 Jan 2013
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hodgkin's DiseaseStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, National Institutes of Health (NIH), National Cancer Institute (NCI), Harris County Hospital District
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555892
- Sponsor's protocol ID
- H-29617-GRALE
- Other IDs
- GRALE, P50CA126752
- Acronym
- GRALE
- Status last verified
- Feb 2026
- First submitted
- 13 Mar 2012
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sarathkumara YD, Van Bibber NW, Liu Z, Heslop HE, Rouce RH, Coghill AE, Rooney CM, Proietti C, Doolan DL. Differential antibody response to EBV proteome following EBVST immunotherapy in EBV-associated lymphomas. Blood Adv. 2025 Apr 8;9(7):1658-1669. doi: 10.1182/bloodadvances.2024014937.
PubMed 39908567Sharma S, Mehta NU, Sauer T, Rollins LA, Dittmer DP, Rooney CM. Cotargeting EBV lytic as well as latent cycle antigens increases T-cell potency against lymphoma. Blood Adv. 2024 Jul 9;8(13):3360-3371. doi: 10.1182/bloodadvances.2023012183.
PubMed 38640255
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Administration of Rapidly Generated EBV-Specific Cytotoxic T-Lymphocytes To Patients With EBV-Positive Lymphoma
- ClinicalTrials.gov ID
- NCT01555892
- Acronym / sponsor ID
- GRALE / H-29617-GRALE
- Keywords
- EBV, Hodgkin's Lymphoma, Non-Hodgkin's Lymphoma, Lymphoma Relapse, Autologous or Syngeneic Stem Cell Transplant, T/NK-lymphoproliferative disease, LMP, BARF1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The Methodist Hospital Research Institute, Center for Cell and Gene Therapy, Baylor College of Medicine, National Institutes of Health (NIH), National Cancer Institute (NCI), Harris County Hospital District
- Study start
- 14 Jan 2013 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Mar 2012 (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.
Subjects have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease or severe chronic active Epstein Barr Virus (CAEBV) which has come back, is at risk of coming back, or has not gone away after treatment, including the best treatment investigators know for these diseases.
Some of these patients show signs of virus that is called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono" or the "kissing disease") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with HD and NHL, suggesting that it may play a role in causing Lymphoma. The cancer cells and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. Investigators want to see if special white blood cells, called GRALE T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor.
Investigators have used this sort of therapy to treat a different type of cancer called post transplant lymphoma. In this type of cancer the tumor cells have 9 proteins made by EBV on their surface. Investigators grew T cells in the lab that recognized all 9 proteins and were able to successfully prevent and treat post transplant lymphoma. However, in HD and NHL, T/NK-lymphoproliferative disease, and CAEBV, the tumor cells and B cells only express 4 EBV proteins. In a previous study, the investigators made T cells that recognized all 9 proteins and gave them to patients with HD. Some patients had a partial response to this therapy but no patients had a complete response. The investigators then did follow up studies where investigators made T cells that recognized the 2 EBV proteins seen in patients with lymphoma, T/NK-lymphoproliferative disease and CAEBV. Investigators have treated over 50 people on those studies. About 60% of those patients who had disease at the time they got the cells had responses including some patients with complete responses. This study will expand on those results and the investigators will try and make the T cells in the lab in a simpler faster way. These cells are called GRALE T cells. These GRALE T cells are an investigational product not approved by the FDA.
The purpose of this study is to find the largest safe dose of LMP-specific cytotoxic GRALE T cells created using this new manufacturing technique. Investigators will learn what the side effects are and to see whether this therapy might help patients with HD or NHL or EBV associated T/NK-lymphoproliferative disease or CAEBV.
Detailed description
Subjects (or their syngeneic donor) will give blood for investigators to make EBV-specific (GRALE) T cells in the lab. These cells will be grown and frozen for the subject.
In this study, patients may also receive cyclophosphamide and fludarabine. These two drugs are standard chemotherapy medicines and may be given before the T cells to make space in the blood for the T cells to grow after receiving them. These drugs will be given intravenously daily over three days.
The GRALE T cells will then be thawed and injected into the subject over 1-10 minutes. Initially, two doses of GRALE T cells will be given 2 weeks apart.
If after the 2nd infusion there is a demonstrated partial response or stable disease in the size of the lymphoma on CT or MRI scan as assessed by a radiologist, the subject can receive additional doses of the GRALE T cells if they wish (up to 6 times). Follow up testing will be collected just like after the 1st infusion.
All of the treatments will be given by the Center for Cell and Gene Therapy at Texas Children's Hospital or Houston Methodist Hospital.
Investigators will follow the subjects after the injections. They will either be seen in the clinic or the subject will be contacted by a research nurse yearly for 5 years.
If they receive additional doses of the GRALE T cells as described above, they will be followed until 5 years after the last dose of GRALE T-cells.
For patients who receive more than one infusion, follow up will continue every 3 months until 12 months after the last infusion, then yearly thereafter for 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EBV-specific T cells: A | Experimental | Biological: EBV-specific T cells: AGroup A: Patients in second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiple relapsed patients in remission who are at a high risk of relapse)** or any patient with primary disease or in first or subsequent remission if immunosuppressive chemotherapy is contraindicated. Patients may receive cells with or without lymphodepletion. Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule: Day 0: 1 x 10^8 cells/m2 Day 14: 2 x 10^8 cells/m2 ** Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant. |
| EBV-specific T cells: B | Experimental | Biological: EBV-specific T cells: BGroup B: Patients in remission or with minimal residual disease (MRD) status after autologous or syngeneic SCT. Patients may receive cells with or without lymphodepletion. Patients will be treated at Dose Level 3. Each patient will receive 2 injections, 14 days apart, according to the following dosing schedule: Day 0: 1 x 10^8 cells/m2 Day 14: 2 x 10^8 cells/m2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component
- EBV positive tumor (can be pending at this time)
- Weighs at least 12kg
- Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
- Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)* and
Key exclusion criteria (4 listed)
- 1. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)
- Pregnant or lactating
- Severe intercurrent infection.
- Current use of systemic corticosteroids > 0.5 mg/kg/day
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 |
|---|---|---|
| EBV-specific T cells: AAlso: LMP, BARF1 and EBNA1 specific CTLsPatients may receive cells with or without lymphodepletion. Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2 | Biological | EBV-specific T cells: A |
| EBV-specific T cells: BPatients may receive cells with or without lymphodepletion. Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2 | Biological | EBV-specific T cells: B |
Primary outcome
Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 T lymphocytes
Time frame: 8 weeks
To determine the safety of escalating doses of 2 intravenous injections of autologous or syngeneic rapid LMP, BARF1 and EBNA1 specific T-lymphocytes (VSTs) in patients with EBV-associated Hodgkin's Disease or non-Hodgkin's lymphoma or T/NK-lymphoproliferative disease and CAEBV.
2 secondary outcomes
Determine survival and immune function of LMP/BARF1/EBNA1-specific cytotoxic T-lymphocyte lines
Time frame: 1 year
Assess anti-viral and anti-tumor effects of LMP/BARF1/EBNA1-specific EBVST
Time frame: 1 year
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 2 Mar 2026.
- Derived from this study: PubMed 39908567Sarathkumara YD, Van Bibber NW, Liu Z, Heslop HE, Rouce RH, Coghill AE, Rooney CM, Proietti C, Doolan DL. Differential antibody response to EBV proteome following EBVST immunotherapy in EBV-associated lymphomas. Blood Adv. 2025 Apr 8;9(7):1658-1669. doi: 10.1182/bloodadvances.2024014937.
- Derived from this study: PubMed 38640255Sharma S, Mehta NU, Sauer T, Rollins LA, Dittmer DP, Rooney CM. Cotargeting EBV lytic as well as latent cycle antigens increases T-cell potency against lymphoma. Blood Adv. 2024 Jul 9;8(13):3360-3371. doi: 10.1182/bloodadvances.2023012183.
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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.
Helen E Heslop, MD principal investigator
Baylor College of Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EBV-specific T cells: A and EBV-specific T cells: B in people with Hodgkin's Disease and Non-Hodgkin's Lymphoma, run by Baylor College of Medicine at 3 sites 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 18 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Contact Helen E Heslop, MD (832-824-4662, hheslop@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of toxicity of escalating doses of LMP, BARF1 and EBNA1 T lymphocytes (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01555892, which also lists 2 linked publications.
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 2 Mar 2026.