NCT02912897 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
| NCT ID | NCT02912897 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Nantes University Hospital |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 7 participants |
| Start Date | 2021-01-26 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 7 participants in total. It began in 2021-01-26 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02912897 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02912897 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT02912897 currently recruiting?
Yes, NCT02912897 is actively recruiting participants. Contact the research team at david.laplaud@univ-nantes.fr for enrollment information.
Where is the NCT02912897 trial being conducted?
This trial is being conducted at Nantes, France.
Who is sponsoring the NCT02912897 clinical trial?
NCT02912897 is sponsored by Nantes University Hospital. The trial plans to enroll 7 participants.
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