There is one clinical trial.
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 biological markers of disease activity in cerebral spinal fluid in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).
In "Open-label Extension" period, participants will receive 1 cycle of ATA188 treatment every 12 months (Q12M) for up to 4 years (ie, Years 2 to 5). --- Q12M ---
Participants who complete Year 2 will enter in OLE period to receive ATA188 Q12M for up to 3 years (ie, Years 3 to 5) at the RP2D received in the double-blind period (Year 1 and Year 2). --- Q12M ---
Description: Safety and tolerability
Measure: Part 1 and Part 2: Incidence of adverse events Time: At 12 months after the first dose of study drugDescription: Dose assessment
Measure: Part 1: Recommended Part 2 dose of ATA188 monotherapy Time: Day 1 to Day 35 of Cycle 1 for each participant in dose escalation part (approximately 1 year)Description: Antibody assessment and quantification
Measure: Part 2: Change from baseline in immunoglobulin G (IgG) index, including quantification of IgG production Time: At 12 months after the first dose of study drugDescription: Changes in disability score
Measure: Part 1: Change from baseline in expanded disability status scale (EDSS) score Time: At 12 months after the first dose of study drugDescription: Changes in disability score
Measure: Part 2: Change from baseline in clinical disability as assessed by the EDSS score and/or Timed 25 foot Walk (T25W) and/or 9-hole Peg Test (9HPT) Time: At 12 months after the first dose of study drugDescription: Change in MRI activity
Measure: Part 2: Change from baseline in cervical spinal cord volume and whole brain volume on MRI scans Time: At 12 months after the first dose of study drugDescription: Change in MRI activity
Measure: Part 2: Change from baseline in the number of Gadolinium-enhancing and new or enlarging T2 lesions on brain MRI scans Time: At 12 months after the first dose of study drug