Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy with Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients with a First Clinical Episode Highly Suggestive of Multiple Sclerosis
* A clinically isolated syndrome (first acute or sub acute neurological event consistent with demyelination \[i.e. optic neuritis, spinal cord syndrome, brainstem/ cerebellar syndrome\])
* And a MRI scan showing dissemination of MRI lesions in space based on 2017 McDonald criteria At least 1 lesion detected in 2 or more following locations (sites) periventricular, cortical or juxtacortical, infratentorial, spinal cord
* With a possible dissemination in time based on the revised McDonald cirteria and evicenced on simultaneous detection of one Gadolinium (Gd) enhancing and non-Gd enhancing lesions
* Or demonstration of CSF-specific oligoclonal bands (OCBs)
EDSS Score \<3
Patients covered by health care insurance (social security)
Written informed consent obtained.
Onset of symptoms occurring within 60 days of inclusion
Patients with HIV, HTLV, Hepatitis B, C Syphilis testing negative within 30 days
Positive EBV serology
White blood cell count (Leukocytes) \> 750/mm3
Negative pregnancy test
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Patients with clinically definite multiple sclerosis
Patients known to have HIV, HTLV Hepatitis A, B, C or Syphilis infections or patient with active uncontrolled systemic bacterial, viral, parasitic or fungal infections.
Patients with white blood cell count (Leukocytes) \< 750/mm3
Pregnant or breast feeding women
Patient with childbearing potentiel refusing efficient contraceptive method
Patients wishing to be pregnant during the course of the study
Patients under legal guardianship
Concomitant participation of any other trial
Patients with mental or psychiatry condition unable to understand the trial
Patients with any medically unstable condition or any health conditions that may impact the safety of the patient as determined by the investigator or patient with any stable condition treated with immunotherapy
Patients with a history of cancer within 5 years or progressive cancer except for basal or cell skin lesions surgically excised and cured, in situ cervical cancer
Patients unable to comply with protocol.
Contraindication for MRI or/and any known history of hypersensitivity to contrast medium
Patients currently treated with immunosuppressive drugs including oral or systemic corticosteroids
Clareo Health | Trial to Assess the Safety and Feasibility of Adoptive Cell Therapy with Autologous EBV-specific Cytotoxic T Lymphocytes (CTL) in Patients with a First Clinical Episode Highly Suggestive of Multiple Sclerosis
