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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 April 2023
• Main ID: NCT02912897
• Date of registration: 13/09/2016
• Prospective Registration: Yes
• Primary sponsor: Nantes University Hospital
• Public 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 MS and EBV-CTL
• Scientific title: 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
• Date of first enrolment: January 26, 2021
• Target sample size: 7
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02912897
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

France

Contacts

• Name: David LAPLAUD, Doctor

• Name: David LAPLAUD, Doctor

Key inclusion & exclusion criteria

Inclusion Criteria:

- 18
- 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



Age minimum: 18 Years
Age maximum: 45 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: Cellular therapy with EBV specific autologous CTL infusion

Primary Outcome(s)

Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE [Time Frame: 2 years]

Secondary ID(s)

RC14_0359

Source(s) of Monetary Support

Please refer to primary and secondary sponsors