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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 : Recruiting
First Posted : February 9, 2016
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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

Condition or disease Intervention/treatment Phase
Serologically Active Adult Systemic Lupus Erythematosus Biological: Autologous EBV specific CTL infusion Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : January 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
Experimental: Autologous EBV specific CTL infusion Biological: Autologous EBV specific CTL infusion



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Mohamed Hamidou, PU PH mohamed.hamidou@chu-nantes.Fr

Locations
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France
CHU de Nantes - Dermatologie Active, not recruiting
Nantes, France
CHU de Nantes - Médecine interne Recruiting
Nantes, France
Contact: Mohamed Hamidou, PU PH         
Principal Investigator: Mohamed Hamidou, PU PH         
Hopital La pitié Salpétriere Not yet recruiting
Paris, France
Contact: Zahir Amoura, PU PH         
Principal Investigator: Zahir Amoura, PH PU         
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Study Director: Mohamed Hamidou, PU PH CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT02677688     History of Changes
Other Study ID Numbers: BRD/10/06-X
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: March 12, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nantes University Hospital:
systemic lupus erythematosus
autologous anti-EBV CTL
adoptive therapy
phase 1 -2

Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases