SUMMARY: Investigators are recruiting up to 72 people with primary progressive
or secondary progressive
MS from six sites across the United States (Louisiana, North Carolina, Pennsylvania, Tennessee, Texas, Washington) and in Australia for a phase 1b clinical trial of the investigational medication ATA188. ATA188 targets Epstein-Barr virus, which may play a role in the development of MS, and is administered via intravenous (IV, into a vein) infusion. The study is funded by Atara Biotherapeutics. Additional sites are planned in the US.
This is a study that requires in-person site visits. Strict precautions are being taken to ensure participant safety in light of the COVID-19 pandemic. Learn what you need to know about COVID-19
: Epstein-Barr virus (EBV, which causes mononucleosis), has received significant attention, with a growing number of research findings indicating that previous infection with EBV contributes to the risk of developing MS. ATA188 is an investigational therapy consisting of immune T cells collected from healthy donors that can target immune B cells that have been infected with EBV in the brain and spinal cord. ATA188 is matched to the immune-related genes in each individual. An earlier phase of this study (“Part 1”) suggested that ATA188 was well tolerated and also helped to determine the dose for this study.
Eligibility and Details
: For “Part 2” of this trial, investigators are recruiting participants with progressive MS aged 18 to 55 who have antibodies to EBV as determined by a blood test.
- In the first year of the study,
- participants will be randomly assigned to receive ATA188 or an inactive placebo.
- participants will receive 2 cycles of treatment (each cycle includes three IV infusions) and will be followed for at least 12 months after the first infusion.
- In the second year of the study,
- participants who received placebo in the first year will receive 2 cycles of ATA188 and
- participants who received ATA188 in first year will receive 1 cycle of ATA188 and 1 cycle of placebo.
- Participants who complete Year 2 will receive ATA188 every 12 months (1 cycle)for up to 3 more years.
The primary objective of the study is to determine how the immune system responds to ATA188 and secondary outcomes include measuring changes in disability and monitoring disease activity on MRI scans.
: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the site nearest you listed on clinicaltrials.gov, here
. If there is no study site near you, please check back as additional study sites are being added or you may email email@example.com
Sites are enrolling in the following cities:
New Orleans, Louisiana
Mooresville, North Carolina
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here
Read more about current treatments for primary progressive MS
and secondary progressive MS