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

Recruiting (For Part 1 of the study recruitment has completed, Part 2 continues to recruit participants. )

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

October 19, 2017

Recruitment contacts

Australia, New South Wales

Liverpool Hospital

Recruiting

Liverpool, New South Wales, Australia, 2170

Contact: Patience Murambiwa
+61 (0)2 9616 4690
Patience.Murambiwa@health.nsw.gov.au

Principal Investigator: Suzanne Hodgkinson, MB, BS, PhD

 

Australia, Queensland

Royal Brisbane and Women’s Hospital

Recruiting

Brisbane, Queensland, Australia, 4029

Contact: Nanette Douglas
+61 (0)7 3346 6022
nanette.douglas@uq.edu.au

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

 

Griffith University, School of Medicine

Recruiting

Southport, Queensland, Australia, 4222

Contact: Sofia J Sanchez

+61 (0)7 5678 0750

s.jimenezsanchez@griffith.edu.au

Principal Investigator: Simon A Broadley, MBBS, PhD

 

 

Further details

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

Region

NSW/ACT/SA/VIC/QLD/WA/TAS/NT/NZ

Trial number

NCT03283826

Ethics Approval

Yes

Last updated

26 March 2021

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