Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)

Phase 2TerminatedNCT02677688

Nantes University Hospital9 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Serologically Active Adult Systemic Lupus Erythematosus

Interventions

Autologous EBV specific CTL infusionBIOLOGICAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

CHU de Nantes - Dermatologie

Nantes, France

CHU de Nantes - Médecine interne

Nantes, France

Hopital La pitié Salpétriere

Paris, France

Outcomes

Primary Outcomes

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.

Time frame: month 12

Secondary Outcomes

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)