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

Launched by NANTES UNIVERSITY HOSPITAL · Sep 21, 2016

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients who may have multiple sclerosis (MS). The study focuses on using a type of immune cell, called cytotoxic T lymphocytes (CTL), which are specially trained to fight off the Epstein-Barr virus (EBV). Researchers believe that EBV might play a role in MS, and they aim to see if giving patients their own EBV-specific CTLs can help improve their immune response and manage their symptoms.

To be eligible for this trial, participants must be between 18 and 45 years old and have experienced a first neurological event that suggests MS, such as vision problems or issues with coordination. They also need to have specific findings on an MRI scan and show certain blood test results. Participants will undergo a treatment process that involves their immune cells and will be closely monitored for safety and any effects on their condition. This trial is currently recruiting participants, and it is essential that those interested discuss their eligibility with their healthcare provider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 18\<Age≤45 years
• * Patients with :
• • 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
• Exclusion Criteria:
• • 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