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Report for Clinical Trial NCT03283826

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1, Two-part, Open-label Dose-escalation and Double-blind, Placebo-controlled Dose-expansion Study With an Open-label Extension to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

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]).

NCT03283826 Primary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis
MeSH:Multiple Sclerosis Multiple Sclerosis, Chronic Progressive Sclerosis

2 Interventions

Name: ATA188

Description: ATA188 is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ progressive multiple sclerosis.
Type: Biological
Group Labels: 1

ATA188

Name: Placebo

Description: Placebo matching to ATA188
Type: Drug
Group Labels: 1

Placebo


Primary Outcomes

Description: Safety and tolerability

Measure: Part 1 and Part 2: Incidence of adverse events

Time: At 12 months after the first dose of study drug

Measure: Part 1: Incidence of clinically significant changes in laboratory tests, electrocardiograms (ECGs), and vital signs

Time: At 12 months after the first dose of study drug

Description: 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 drug

Secondary Outcomes

Description: 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 drug

Description: 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 drug

Description: 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 drug

Description: 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

Purpose: Treatment

Allocation: Randomized

Sequential Assignment


There are 2 SNPs

SNPs


1 Q12M

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 ---


2 T25W

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). --- T25W ---



HPO Nodes