Epstein-Barr Virus InfectionsPhase 1SCAEBVNCT00058591
Treating Severe Chronic Epstein-Barr Virus (EBV) Infection With EBV Specific Cytotoxic T Lymphocytes (CTLs)
A Phase 1 study testing Intravenous injection of EBV specific CTLS in people with Epstein-Barr Virus Infections, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing)… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epstein-Barr Virus Infections
- What is being tested?
- Intravenous injection of EBV specific CTLS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2000to Dec 2008
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Patients must have severe chronic EBV infection as manifested by 6 months of symptoms Either elevated peripheral blood EBV DNA (>4000 genomes per ug PBMC DNA) or free EBV DNA in serum or CSF or VCA antibody titer > 1/640
- Seronegative for HIV
- Not on investigational agents in the last 4 weeks
- Signed informed consent obtained from patient/guardian
- CTLs available
- Performance status; Karnofsky >60
Show all 10Show fewer
- Creatinine < 3X normal
- Bilirubin < 5X normal
- Normal electrolytes, calcium, phosphorus, nutritional status
- Females with child-bearing potential must utilize effective birth control.
Who cannot join
- Patients with a severe intercurrent infection
- Patients that recently received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
- Patients with life expectancy of less than 6 weeks
- Pregnant or lactating females
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas Children's Hospital
Houston, Texas, 77030
The Methodist Hospital
Houston, Texas, 77030
About this study
Official title: Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection
Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available.
This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient.
The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.
Read the detailed description
Ten to sixty ml (2-12 teaspoons) of blood will be collected from the patient which we use to grow the T cells. These T cells are then stimulated with EBV infected cells (which have been treated with radiation so that they cannot grow). This stimulation trains the T cells to kill EBV infected cells. We then test the T cells to make sure that they kill the EBV infected cells.
Therapy can take place in one of the specifically designated outpatient clinics so hospital admission is not required. First, patients will be given doses of Tylenol (for any aches/pains) and Benadryl (for any minor allergic reactions such as itching/rash). Next, the T cells will be injected into a vein over a 10 minute period. Patients will be closely watched for any side effects.
If a patient shows some response to the treatment they may receive up to three additional T cell injections at three month intervals. Patients will need to be seen every other week in the clinic for six weeks after the injection. Following that, patients will either be seen in the clinic or contacted by one of the research staff working on this study, once a month for one year.
To learn more about the way the T cells are working and how long they last in the body, an extra 40 mls(8 teaspoonfuls) of blood will be taken at these visits. Additionally, 3 mls (1/2 teaspoonful) of blood will be taken prior to the infusion and monthly thereafter to conduct a CBC (a test to look at the components of the blood).
- Conditions
- Epstein-Barr Virus Infections
- Being tested
- Intravenous injection of EBV specific CTLS
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous injection of EBV specific CTLSBiological
The dose levels for this study are as follows:
Level Dose
- 2 x 107 CTLs/m2
- 5 x 107 CTLs/m2
- 1 x 108 CTLs/m2
If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment dose levels 1, 2 and 3 Receives: Biological: Intravenous injection of EBV specific CTLS |
What is being measured
The primary outcome is the main question the study is designed to answer.
to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection
Measured: 1 yr
Secondary outcomes (2)
determine antiviral and immunological efficacy of intravenous injections of CTLs in these patients
Measured: 1 yr
assess the clinical effects of these injections
Measured: 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2003 (estimated)
- Study startJan 2000
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epstein-Barr Virus InfectionsStudies 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
- 13 participants (actual)
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
- Responsible party
- Principal investigator, Helen Heslop, Baylor College of Medicine
- Investigators
- Helen E Heslop, MD, Principal investigator, Center for Cell and Gene Therapy, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00058591
- Sponsor's protocol ID
- H8216
- Other IDs
- SCAEBV
- Acronym
- SCAEBV
- Status last verified
- Jan 2020
- First submitted
- 8 Apr 2003
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous EBV Specific CTLs for Therapy of Severe Chronic EBV Infection
- ClinicalTrials.gov ID
- NCT00058591
- Acronym / sponsor ID
- SCAEBV / H8216
- Conditions
- Epstein-Barr Virus Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- 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
- Study start
- Jan 2000
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 9 Apr 2003 (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.
Severe chronic active Epstein-Barr virus (SCAEBV) is a rare Epstein-Barr virus (EBV or commonly known as mono or the kissing disease) associated disorder. This disorder may cause chronic tiredness and fevers and sometimes be complicated by life threatening problems such as multi-organ failure, chronic (ongoing) pneumonia, and lymphoproliferative diseases (diseases involving the lymph nodes which could eventually show up as leukemia or a tumor). The reasons for the body's inability to control the EBV infection are still unknown and no effective treatment is currently available.
This research study uses Epstein-Barr virus (EBV) specific cytotoxic T lymphocytes (CTLs). We want to see if we can grow special white blood cells, called T cells, that have been trained to kill EBV infected cells in the laboratory and see if these cells may help control the EBV infection when given back to the patient.
The purpose of this study is to find the largest safe dose of EBV specific CTLs, to learn what the side effects are, and to see whether this therapy might help the body fight off the SCAEBV infection.
Detailed description
Ten to sixty ml (2-12 teaspoons) of blood will be collected from the patient which we use to grow the T cells. These T cells are then stimulated with EBV infected cells (which have been treated with radiation so that they cannot grow). This stimulation trains the T cells to kill EBV infected cells. We then test the T cells to make sure that they kill the EBV infected cells.
Therapy can take place in one of the specifically designated outpatient clinics so hospital admission is not required. First, patients will be given doses of Tylenol (for any aches/pains) and Benadryl (for any minor allergic reactions such as itching/rash). Next, the T cells will be injected into a vein over a 10 minute period. Patients will be closely watched for any side effects.
If a patient shows some response to the treatment they may receive up to three additional T cell injections at three month intervals. Patients will need to be seen every other week in the clinic for six weeks after the injection. Following that, patients will either be seen in the clinic or contacted by one of the research staff working on this study, once a month for one year.
To learn more about the way the T cells are working and how long they last in the body, an extra 40 mls(8 teaspoonfuls) of blood will be taken at these visits. Additionally, 3 mls (1/2 teaspoonful) of blood will be taken prior to the infusion and monthly thereafter to conduct a CBC (a test to look at the components of the blood).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Intravenous injection of EBV specific CTLSTreatment dose levels 1, 2 and 3 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients must have severe chronic EBV infection as manifested by 6 months of symptoms Either elevated peripheral blood EBV DNA (>4000 genomes per ug PBMC DNA) or free EBV DNA in serum or CSF or VCA antibody titer > 1/640
- Seronegative for HIV
- Not on investigational agents in the last 4 weeks
- Signed informed consent obtained from patient/guardian
- CTLs available
Key exclusion criteria (4 listed)
- Patients with a severe intercurrent infection
- Patients that recently received high dose steroids within the last week or other immunosuppressive drugs within a week (or longer as indicated by the half life of the agent)
- Patients with life expectancy of less than 6 weeks
- Pregnant or lactating females
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 |
|---|---|---|
| Intravenous injection of EBV specific CTLSThe dose levels for this study are as follows: Level Dose 1. 2 x 107 CTLs/m2 2. 5 x 107 CTLs/m2 3. 1 x 108 CTLs/m2 If patients have a clinical response to the first infusion defined by an improvement in the fatigue score or resolution of clinical abnormalities such as lymphadenopathy or an improvement in laboratory parameters such as a decrease in VCA titer or reduction in free EBV DNA they will be eligible to receive up to 3 additional injections of CTLs at the original dose at 3 monthly intervals. | Biological | Treatment |
Primary outcome
to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection
Time frame: 1 yr
2 secondary outcomes
determine antiviral and immunological efficacy of intravenous injections of CTLs in these patients
Time frame: 1 yr
assess the clinical effects of these injections
Time frame: 1 yr
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
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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 E Heslop, MD principal investigator
Center for Cell and Gene Therapy, Baylor College of Medicine
2 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 Intravenous injection of EBV specific CTLS in people with Epstein-Barr Virus Infections, run by Baylor College of Medicine at 2 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 10 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to determine the safety of intravenous injections of autologous EBV specific cytotoxic T cell lines in individuals with severe chronic EBV infection (time frame: 1 yr). 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 18 Jan 2020.