Assessing safety and feasibility of cell therapy for early multiple sclerosis
An Open Single-center, Phase I Proof of Concept 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
PHASE1 · Nantes University Hospital · NCT02912897
This study is testing a new cell therapy using immune cells from patients to see if it can help people aged 18 to 45 who are having their first signs of multiple sclerosis.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 7 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Nantes University Hospital (other) |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Nantes) |
| Trial ID | NCT02912897 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and feasibility of using autologous Epstein-Barr virus (EBV)-specific cytotoxic T lymphocytes (CTL) in patients experiencing their first clinical episode suggestive of multiple sclerosis (MS). The study focuses on patients aged 18 to 45 who have a clinically isolated syndrome and meet specific MRI and cerebrospinal fluid criteria. By infusing these specially targeted immune cells, the trial aims to understand their potential role in managing MS, which is thought to be linked to EBV infection. The approach seeks to address the altered immune response observed in MS patients and explore a novel cellular therapy.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 45 who have experienced a first acute neurological event consistent with demyelination and meet specific MRI and CSF criteria.
Not a fit: Patients with advanced multiple sclerosis or those with other significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option that targets the underlying immune dysfunction associated with multiple sclerosis.
How similar studies have performed: While the link between EBV and multiple sclerosis is supported by epidemiological evidence, this specific approach using autologous CTL is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Nantes
- University Hospital — Nantes, France (RECRUITING)
Study contacts
- Study coordinator: David LAPLAUD, Doctor
- Email: david.laplaud@univ-nantes.fr
- Phone: + 33 (0)2 40 16 52 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Multiple Sclerosis, EBV-CTL, Multiple sclerosis, cellular therapy