Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE Treatment
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 3
- 主要终点
- description of adverse events according CTC toxicity criteria .
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
description of adverse events according CTC toxicity criteria .
时间窗: month 12
Tolerance will be assessed by clinical and laboratory examinations to each Visit according to CTC toxicity criteria.
次要结局
- Lupus Quality of Life(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Systemic Lupus Erythematosus biological activity (2)(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Systemic Lupus Erythematosus biological activity (1)(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Systemic Lupus Erythematosus biological activity (4)(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Quality of Life, The Short Form (36) Health Survey(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Systemic Lupus Erythematosus biological activity (3)(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)
- Systemic Lupus Erythematosus clinical activity(day 0, day 10, week 4, month 3, month 6, month 9 and month 12)