Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE) (LUPUS CTL EBV)
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|ClinicalTrials.gov Identifier: NCT02677688|
Recruitment Status : Active, not recruiting
First Posted : February 9, 2016
Last Update Posted : April 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Serologically Active Adult Systemic Lupus Erythematosus||Biological: Autologous EBV specific CTL infusion||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 2016|
|Estimated Primary Completion Date :||September 1, 2021|
|Estimated Study Completion Date :||September 1, 2021|
|Experimental: Autologous EBV specific CTL infusion||
Biological: Autologous EBV specific CTL infusion
- 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.
- Systemic Lupus Erythematosus clinical activity [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]Composite Response of SLE Index (Systemic Lupus Erythematosus Responder Index: Systemic Lupus Erythematosus Disease Activity Index + British Isles Lupus Assessment Group + Physician Global Assessment)
- 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 ]The Short Form (36) Health Survey
- Lupus Quality of Life [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]Lupus Quality of Life questionnaire
- Systemic Lupus Erythematosus biological activity (1) [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]biological parameter measurement biomarkers C3
- Systemic Lupus Erythematosus biological activity (2) [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]biological parameter measurement biomarkers C4
- Systemic Lupus Erythematosus biological activity (3) [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]biological parameter measurement biomarkers anti-dsDNA antibodies
- Systemic Lupus Erythematosus biological activity (4) [ Time Frame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12 ]biological parameter EBV blood load
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677688
|CHU de Nantes - Dermatologie|
|CHU de Nantes - Médecine interne|
|Hopital La pitié Salpétriere|
|Study Director:||Mohamed Hamidou, PU PH||CHU de Nantes|