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

Serologically Active Adult Systemic Lupus Erythematosus Clinical Trial

— LUPUS CTL EBV  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02677688
• Other study ID #: BRD/10/06-X
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: July 1, 2021

Study information

• Verified date: March 2022
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Serologically Active Adult Systemic Lupus Erythematosus

Intervention

Biological:
• Autologous EBV specific CTL infusion

Locations

Country	Name	City	State
France	CHU de Nantes - Dermatologie	Nantes
France	CHU de Nantes - Médecine interne	Nantes
France	Hopital La pitié Salpétriere	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	month 12
Secondary	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)	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Quality of Life, The Short Form (36) Health Survey	The Short Form (36) Health Survey	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Lupus Quality of Life	Lupus Quality of Life questionnaire	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Systemic Lupus Erythematosus biological activity (1)	biological parameter measurement biomarkers C3	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Systemic Lupus Erythematosus biological activity (2)	biological parameter measurement biomarkers C4	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Systemic Lupus Erythematosus biological activity (3)	biological parameter measurement biomarkers anti-dsDNA antibodies	day 0, day 10, week 4, month 3, month 6, month 9 and month 12
Secondary	Systemic Lupus Erythematosus biological activity (4)	biological parameter EBV blood load	day 0, day 10, week 4, month 3, month 6, month 9 and month 12