Clinical trial NCT02677688: Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Serologically Active Adult Systemic Lupus Erythematosus
Keywords: systemic lupus erythematosus
autologous anti-EBV CTL
adoptive therapy
phase 1 -2
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* Consent Refusal
* Pregnancy
* Nursing women

Primary outcomes:
measure: description of adverse events according CTC toxicity criteria .
timeFrame: month 12
Secondary outcomes:
measure: Systemic Lupus Erythematosus clinical activity
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Quality of Life, The Short Form (36) Health Survey
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Lupus Quality of Life
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Systemic Lupus Erythematosus biological activity (1)
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Systemic Lupus Erythematosus biological activity (2)
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Systemic Lupus Erythematosus biological activity (3)
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
measure: Systemic Lupus Erythematosus biological activity (4)
timeFrame: day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU de Nantes - Dermatologie
city: Nantes
country: France
facility: CHU de Nantes - Médecine interne
city: Paris
country: France
facility: Hopital La pitié Salpétriere
Study officials:
affiliation: Nantes University Hospital
name: Mohamed Hamidou, PU PH
role: STUDY_DIRECTOR
References: