Phase I clinical trial of autologous Epstein–Barr virus-specific T cell therapy as treatment of progressive multiple sclerosis

Phase 1

Completed

• Conditions: Neurological - Multiple sclerosis; multiple sclerosis

• Registration Number: ACTRN12615000422527
• Lead Sponsor: QIMR Berghofer Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-04
• Study Completion: 2018-01-09
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. Primary progressive or secondary progressive MS
2. Positive EBV serology
3. Age 18 years or above
4. Provision of informed consent
5. EDSS score of 5.0–8.0 (Kurtzke Expanded Disability Status Scale)
6. Life expectancy of at least 6 months, as determined by the Clinical Investigator

Exclusion Criteria

1. Positive serology and/or nucleic acid testing (NAT) for human immunodeficiency virus (HIV)
2. Serology and/or NAT indicating active hepatitis B virus (HBV) infection or carrier status for HBV
3. Serology and/or NAT indicating active hepatitis C virus (HCV) infection
4. Positive serology for syphilis or human T cell lymphotrophic virus (HTLV I/II)
5. Significant non-malignant disease (e.g. severe cardiac or respiratory dysfunction)
6. Uncontrolled psychosis, uncontrolled depression, substance dependence, or any other psychiatric condition that may compromise the ability to participate in this trial
7. Inability to provide informed consent, including patients with severe cognitive impairment, intellectual disability, or mental illness
8. Clinically significant abnormalities of full blood count, renal function, or hepatic function
9. Any contraindication to Magnetic Resonance Imaging (MRI)
10. Prior cancers, except those diagnosed >5 years ago with no evidence of disease recurrence and clinical expectation of recurrence of <5%, or successfully treated non-melanoma skin cancer, or carcinoma in situ of the cervix
11. Immunomodulatory therapy (apart from short courses of corticosteroids) within the past year
12. Pregnant or unwilling to use adequate contraception

Study & Design

• Study Type: Interventional
• Study Design: Not specified