Clinical Trials

Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis

Type of Study/Intervention

Medical Therapy

Recruitment Status


Form of MS

Secondary progressive MS, Primary progressive MS

Brief 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 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]).

Inclusion criteria

  • For Part 2: 18 to < 56 years of age (18 to < 66 years of age for Part 1, which has finished recruitment)
  • Positive EBV serology
  • Current diagnosis of a progressive form of MS as defined by the 2017 Revised McDonald criteria for Part 2 (History of progressive forms of MS as defined by the 2010 Revised McDonald criteria for the diagnosis of MS for Part 1, which has finished recruitment)
  • EDSS scores of 3.0 to 6.5 for Part 2 (EDSS scores of 3.0 to 7.0 for Part 1, which has finished recruitment)

Exclusion criteria

  • Clinical relapse as follows: For Part 2: Documented clinical and/or radiological relapse for 2 years prior to screening, including gadolinium (Gd)-enhancing lesion(s) on any brain MRI scans available during this period (A participant will also be considered ineligible if any clinical and/or radiological relapse is reported between screening and the first dose of study drug.); For Part 1: Active clinical relapse between providing informed consent and the first dose of study drug
  • Concurrent serious uncontrolled or unresolved medical condition
  • Positive serology and/or nucleic acid testing (NAT) for human immunodeficiency virus (HIV), active hepatitis B virus (HBV) infection or carrier status for HBV, active hepatitis C virus (HCV) infection
  • Positive serology for syphilis or human T cell lymphotrophic virus I/II (HTLV)
  • Clinically significant abnormalities of full blood count, renal function, or hepatic function
  • Any contraindication to MRI and/or Gd, eg., any object that is reactive to strong static magnetic, pulsed-gradient fields including any metallic fragments or foreign body (eg, aneurysm clip[s], pacemakers, electronic implants, shunts)
  • Prior therapy with corticosteroids (2 weeks before Cycle 1 Day 1)
  • Prior therapy (6 half-lives or 30 days, whichever is longer) with glatiramer acetate, interferon (IFN) β, dimethyl fumarate, B-cell depleting agent, methotrexate, azathioprine, cyclosporine, fingolimod, natalizumab, teriflunomide, mitoxantrone, cyclophosphamide, any other immunosuppressant or cytotoxic therapy (other than steroids), antithymocyte globulin or similar anti-T cell antibody therapy, or any other investigational product for Parts 1 and 2, and cladribine for Part 1 and IV immunoglobin, plasmapheresis, Bruton’s tyrosine kinase inhibitors, all sphingosine 1-phosphate receptor modulators for Part 2
  • Previous treatment with alemtuzumab, stem cell transplant, or EBV T-cell therapy for both parts and cladribine for Part 2
  • Unwilling to use protocol specified contraceptive methods
  • Women who are breastfeeding
  • Pregnancy


Note: lumbar puncture is mandatory for Part 2 (optional for subjects enrolled in Part 1, which has finished recruitment)

Anticipated start date

Recruitment has closed.

Recruitment contacts

Australia, New South Wales

Liverpool Hospital


Liverpool, New South Wales, Australia, 2170

Contact: Patience Murambiwa
+61 (0)2 9616 4690

Principal Investigator: Suzanne Hodgkinson, MB, BS, PhD


Australia, Queensland

Royal Brisbane and Women’s Hospital


Brisbane, Queensland, Australia, 4029

Contact: Nanette Douglas
+61 (0)7 3346 6022

Principal Investigator: Zara Ioannides, MBBS, BSC, FRACP, Mphil


Griffith University, School of Medicine


Southport, Queensland, Australia, 4222

Contact: Sofia J Sanchez

+61 (0)7 5678 0750

Principal Investigator: Simon A Broadley, MBBS, PhD



Further details

Full details of the trial can be found on the website, and further information on ATA188 at Atara Biotherapeutics.



Trial number


Ethics Approval


Last updated


Contact Us

We're not around right now. But you can send us an email and we'll get back to you, asap.

Start typing and press Enter to search