Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
Summary
The purpose of this study is to evaluate the safety and tolerability of ATA188 as a monotherapy in Parts 1 and 2, to determine the recommended Part 2 dose (RP2D) of ATA188 as monotherapy in Part 1, and to evaluate the effect of ATA188 treatment on clinical disability, as assessed by confirmed Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis \[PPMS\] and secondary progressive multiple sclerosis \[SPMS\]).
Timeline
- Start
- 2017-10-19
- Primary completion
- 2023-11-09
- Completion
- 2024-01-17
Outcome
Missed primary endpoint
Stopped: “Study was terminated as primary endpoint was not achieved”
release “Phase 2 EMBOLD study of ATA188 in non-active progressive multiple sclerosis (PMS). The study did not meet the primary endpoint” atarabio.com ↗
Publications
- Background Pender MP, Csurhes PA, Smith C, Beagley L, Hooper KD, Raj M, Coulthard A, Burrows SR, Khanna R. Epstein-Barr virus-specific adoptive immunotherapy for progressive multiple sclerosis. Mult Scler. 2014 Oct;20(11):1541-4. doi: 10.1177/1352458514521888. Epub 2014 Feb 3.
- Background Pender MP, Csurhes PA, Burrows JM, Burrows SR. Defective T-cell control of Epstein-Barr virus infection in multiple sclerosis. Clin Transl Immunology. 2017 Jan 20;6(1):e126. doi: 10.1038/cti.2016.87. eCollection 2017 Jan.
- Drosu N, Bjornevik K, Bilodeau PA, Yeh A, Lechner-Scott J, Hawkes CH, Giovannoni G, Levy M. In the era of antiviral trials for MS, the answer lies in the details. Mult Scler Relat Disord. 2024 Feb;82:105444. doi: 10.1016/j.msard.2024.105444. Epub 2024 Jan 12. No abstract available.
- Giovannoni G, Hawkes CH, Lechner-Scott J, Levy M, Yeh EA. Emboldened or not: The potential fall-out of a failed anti-EBV trial in multiple sclerosis. Mult Scler Relat Disord. 2024 Jan;81:105364. doi: 10.1016/j.msard.2023.105364. Epub 2023 Dec 10. No abstract available.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | EVRULEUCEL | Cell therapy | — | Intravenous |