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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

Tracking Information
First Submitted Date  ICMJE January 28, 2016
First Posted Date  ICMJE February 9, 2016
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02677688 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2016)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous EBV-specific Cytotoxic T Cells for the Treatment of Systemic Lupus Erythematosus (SLE)
Official Title  ICMJE Restauration of EBV Control in SLE Phase 1-2 Trial Evaluating Adoptive Transfer of Autologous EBV- Specific Cytotoxic T Lymphocytes in SLE 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Serologically Active Adult Systemic Lupus Erythematosus
Intervention  ICMJE Biological: Autologous EBV specific CTL infusion
Study Arms  ICMJE Experimental: Autologous EBV specific CTL infusion
Intervention: Biological: Autologous EBV specific CTL infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 4, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2020
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed Hamidou, PU PH mohamed.hamidou@chu-nantes.Fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02677688
Other Study ID Numbers  ICMJE BRD/10/06-X
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Nantes University Hospital
Study Sponsor  ICMJE Nantes University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mohamed Hamidou, PU PH CHU de Nantes
PRS Account Nantes University Hospital
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP