Last updated on April 2019

Phase 1 Study to Evaluate the Safety of ATA188 in Subjects With Progressive and Relapsing-Remitting Multiple Sclerosis

Brief description of study

The purpose of this study is to evaluate the safety and tolerability of adoptive transfer of ATA188, as a monotherapy and to determine the recommended Phase 2 dose (RP2D) of ATA188 as monotherapy in subjects with progressive forms of MS and in subjects with relapsing-remitting multiple sclerosis (RRMS).

Detailed Study Description

This is a multicenter, open-label, two-population, single-arm study with a sequential, interpatient dose-escalation and dose expansion in adult subjects with progressive forms of MS (Population A) and in adult subjects with RRMS (Population B).

This study will evaluate the safety of ATA188 administered by intravenous (IV) infusion. ATA188 will be selected for each subject based on matching at least 2 human leukocyte antigen (HLA) alleles shared between ATA188 and the subject including at least 1 HLA-restricting allele.

Beginning 28 days after the last infusion, subjects will enter a follow-up period with 12 monthly (every 28 5 days) visits and an end-of-study (EOS) visit at 24 months after Cycle 1 Day 1. Together, subjects will be observed for 2 years after the first dose of ATA188.

Clinical Study Identifier: NCT03283826

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