Serologically Active Adult Systemic Lupus ErythematosusPhase 1/2LUPUS CTL EBVNCT02677688
Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)
A Phase 1/2 study testing Autologous EBV specific CTL infusion in people with Serologically Active Adult Systemic Lupus Erythematosus, run by Nantes University Hospital at 3 sites in France.
Trial summary
EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Serologically Active Adult Systemic Lupus Erythematosus
- What is being tested?
- Autologous EBV specific CTL infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 3 sitesFrance
- Study dates
- Jan 2016to 1 Jul 2021
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4 systemic lupus criteria of the American College of Rheumatology with antinuclear antibodies> 1:80
- Age greater than or equal to 18 years
- Lupus serologically active without active serious disease (Kidney, CNS)
- Anti-native DNA Ac positive and / or C3 or C4 low
- SLEDAI greater than or equal to 2 at baseline
- Serology HBV, HCV, HIV, HTLV-1, syphilis: Negative J-30 before sample
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- Hemoglobin >11g/dL
- Prednisone dose <15 mg / day with a stable dose within 30 days previous injection
- Immunosuppressive treatments which dosage has not been increased for at least 3 months before enrollment
- Agreement telephone and / or mail for coordinating investigator inclusion
- Social ensured Patient
- EBV positive serology
Who cannot join
- Evolving severe lupus, requiring high dose corticosteroids and / or immunosuppressive therapy
- Psychiatric disorders
- Predicted Failure to monitoring compliance with impossibility
- Infectious Episode underway
- Evolutionary Cancer
- Risk of death within 6 months
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- Consent Refusal
- Pregnancy
- Nursing women
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de Nantes - Dermatologie
Nantes
CHU de Nantes - Médecine interne
Nantes
Hopital La pitié Salpétriere
Paris
About this study
Official title: Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment
EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE
Read the detailed description
Systemic lupus is a disabling disease of the young woman, whose treatment is based on the long-term corticosteroid, anti-malarials and immunosuppressants synthesis. This support is not without potential side effects. EBV is a herpes causes infectious mononucleosis virus, usually encounter in childhood or adolescence, and that our natural immunity cell (CD8 T cells) controls all our lives, not eliminate.
Increasingly scientific studies show that there are patients with systemic lupus (and multiple sclerosis), a failure of self-control of the EBV virus, by T lymphocytes (CD8). This uncontrolled virus then stimulate the B lymphocytes, which produce antibodies, toxic in lupus. The laboratory isolate T cells specific for EBV (EBV-CTL) of a patient, and stimulate in culture to strengthen them. They can be then re-injected by a single intravenous infusion (autotransfusion), and were used to control the virus in certain diseases where EBV has a demonstrated role post-transplant lymphoproliferative disorder, chronic fatigue syndrome EBV-induced.
Our therapeutic approach is completely innovative, as based on the principle of cell therapy, thus not using new drugs, and based on the restoration of the patient's immune system, specific EBV.
- Being tested
- Autologous EBV specific CTL infusion
- Keywords
- systemic lupus erythematosus, autologous anti-EBV CTL, adoptive therapy, phase 1 -2
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous EBV specific CTL infusionBiological
| Study group | Role | What they receive |
|---|---|---|
| Autologous EBV specific CTL infusion | Experimental | Not described Receives: Biological: Autologous EBV specific CTL infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
description of adverse events according CTC toxicity criteria .
Tolerance will be assessed by clinical and laboratory examinations to each Visit according to CTC toxicity criteria.
Measured: month 12
Secondary outcomes (7)
Systemic Lupus Erythematosus clinical activity
Composite Response of SLE Index (Systemic Lupus Erythematosus Responder Index: Systemic Lupus Erythematosus Disease Activity Index + British Isles Lupus Assessment Group + Physician Global Assessment)
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Quality of Life, The Short Form (36) Health Survey
The Short Form (36) Health Survey
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Lupus Quality of Life
Lupus Quality of Life questionnaire
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (1)
biological parameter measurement biomarkers C3
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (2)
biological parameter measurement biomarkers C4
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (3)
biological parameter measurement biomarkers anti-dsDNA antibodies
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (4)
biological parameter EBV blood load
Measured: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startJan 2016
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: completed inclusions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Serologically Active Adult Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Hamidou, PU PH, Study director, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677688
- Sponsor's protocol ID
- BRD/10/06-X
- Acronym
- LUPUS CTL EBV
- Status last verified
- Mar 2022
- First submitted
- 28 Jan 2016
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment
- ClinicalTrials.gov ID
- NCT02677688
- Acronym / sponsor ID
- LUPUS CTL EBV / BRD/10/06-X
- Keywords
- systemic lupus erythematosus, autologous anti-EBV CTL, adoptive therapy, phase 1 -2
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: completed inclusions
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Feb 2016 (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.
EBV has been implicated in pathogeny of SLE with increase in EBV sero-prevalence, defective control in EBV infection and altered both B and T immune responses to this virus The main objective of this pilot proof-of-concept (POC) study is to evaluate safety and efficacy of autologous EBV specific CTL adoptive transfer in adult patients with serologically active SLE
Detailed description
Systemic lupus is a disabling disease of the young woman, whose treatment is based on the long-term corticosteroid, anti-malarials and immunosuppressants synthesis. This support is not without potential side effects. EBV is a herpes causes infectious mononucleosis virus, usually encounter in childhood or adolescence, and that our natural immunity cell (CD8 T cells) controls all our lives, not eliminate.
Increasingly scientific studies show that there are patients with systemic lupus (and multiple sclerosis), a failure of self-control of the EBV virus, by T lymphocytes (CD8). This uncontrolled virus then stimulate the B lymphocytes, which produce antibodies, toxic in lupus. The laboratory isolate T cells specific for EBV (EBV-CTL) of a patient, and stimulate in culture to strengthen them. They can be then re-injected by a single intravenous infusion (autotransfusion), and were used to control the virus in certain diseases where EBV has a demonstrated role post-transplant lymphoproliferative disorder, chronic fatigue syndrome EBV-induced.
Our therapeutic approach is completely innovative, as based on the principle of cell therapy, thus not using new drugs, and based on the restoration of the patient's immune system, specific EBV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous EBV specific CTL infusion | Experimental | Biological: Autologous EBV specific CTL infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 4 systemic lupus criteria of the American College of Rheumatology with antinuclear antibodies> 1:80
- Age greater than or equal to 18 years
- Lupus serologically active without active serious disease (Kidney, CNS)
- Anti-native DNA Ac positive and / or C3 or C4 low
- SLEDAI greater than or equal to 2 at baseline
Key exclusion criteria (9 listed)
- Evolving severe lupus, requiring high dose corticosteroids and / or immunosuppressive therapy
- Psychiatric disorders
- Predicted Failure to monitoring compliance with impossibility
- Infectious Episode underway
- Evolutionary Cancer
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 |
|---|---|---|
| Autologous EBV specific CTL infusion | Biological | Autologous EBV specific CTL infusion |
Primary outcome
description of adverse events according CTC toxicity criteria .
Time frame: month 12
Tolerance will be assessed by clinical and laboratory examinations to each Visit according to CTC toxicity criteria.
7 secondary outcomes
Systemic Lupus Erythematosus clinical activity
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Quality of Life, The Short Form (36) Health Survey
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Lupus Quality of Life
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (1)
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (2)
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (3)
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Systemic Lupus Erythematosus biological activity (4)
Time frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Results and safety
The study was stopped early (reason given: completed inclusions). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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.
Mohamed Hamidou, PU PH study director
Nantes University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous EBV specific CTL infusion in people with Serologically Active Adult Systemic Lupus Erythematosus, run by Nantes University Hospital at 3 sites in France.
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 12 inclusion and 9 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: stopped early, as of the sponsor's last update on 25 Mar 2022. 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 France. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: completed inclusions). Results are not available in the source record.
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?
description of adverse events according CTC toxicity criteria . (time frame: month 12). 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 25 Mar 2022.