Actively Recruiting
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
Led by Nantes University Hospital · Updated on 2025-02-19
7
Participants Needed
1
Research Sites
405 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The etiologic mechanisms involved in multiple sclerosis (MS) are not yet fully understood. Indeed MS is a multifactorial disease involving genetic and environmental factors and Epstein-Barr-Virus (EBV) could be one of these factors. However the link between EBV infection and the immunological mechanisms underlying MS is not clear. Robust sero-epidemiological evidences support an association between EBV infection and MS, and immunological data suggest an altered/deficient immune response against this virus. In healthy individuals EBV produces a persistent infection that is tightly controlled by the immune system. In patients with MS, cellular and humoral immune studies demonstrate an altered response against the virus with a T-cell abnormal reactivity against the EBV-infected autologous B-cells, elevated humoral immune response to Epstein Barr Nuclear Antigen-1, and in the case of children, an increased EBV shedding, demonstrating frequent EBV reactivations. Thus, it has been proposed, that patients with MS present a partially inefficient control of the EBV infection. Some experimental data support the hypothesis suggesting that the presence of autoreactive EBV-B cells in the meninges of patients, probably due to an insufficient clearance of these cells by the immune system, lead to the infiltration of autoreactive T cells. Another hypothesis also suggests a deficient control of the virus, in that case during the inactive phase of the disease. Together, the above data and hypotheses lead to the notion that an immune intervention capable of restoring the host-EBV balance could be beneficial to MS patients In this project, we will assess the feasibility and safety of autologous transfer of several amounts of CD8 T cells directed against autologous EBV transformed B cell lines, in order to finally restore an efficient control of EBV in MS patients. The main objective of the project is to test the feasibility and safety of the process, while efficacy parameters will be also assessed in secondary objectives.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 45 years
- Patients with a clinically isolated syndrome (first acute or subacute neurological event consistent with demyelination such as optic neuritis, spinal cord syndrome, brainstem or cerebellar syndrome)
- MRI showing dissemination of lesions in at least two of the following areas: periventricular, cortical or juxtacortical, infratentorial, spinal cord according to 2017 McDonald criteria
- Possible dissemination in time evidenced by simultaneous detection of Gadolinium-enhancing and non-enhancing lesions
- Or cerebrospinal fluid-specific oligoclonal bands present
- Expanded Disability Status Scale (EDSS) score less than 3
- Covered by health care insurance (social security)
- Written informed consent obtained
- Onset of symptoms within 60 days before inclusion
- Negative tests for HIV, HTLV, Hepatitis B, C, and Syphilis within 30 days
- Positive Epstein-Barr Virus serology
- White blood cell count greater than 750/mm3
- Negative pregnancy test
You will not qualify if you...
- Patients with clinically definite multiple sclerosis
- Known infections with HIV, HTLV, Hepatitis A, B, C, or Syphilis, or active uncontrolled infections
- White blood cell count less than 750/mm3
- Pregnant or breastfeeding women
- Women with childbearing potential not using effective contraception
- Patients planning pregnancy during the study
- Patients under legal guardianship
- Participation in another clinical trial
- Mental or psychiatric conditions preventing understanding of the trial
- Medically unstable or health conditions impacting safety as determined by investigator
- Stable conditions treated with immunotherapy
- History of cancer within 5 years except surgically cured basal or cell skin lesions and in situ cervical cancer
- Inability to comply with the study protocol
- Contraindications for MRI or known hypersensitivity to contrast medium
- Current treatment with immunosuppressive drugs including oral or systemic corticosteroids
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Hospital
Nantes, France
Actively Recruiting
Research Team
D
David LAPLAUD, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here