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

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ClinicalTrials.gov Identifier: NCT03283826
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Atara Biotherapeutics

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Primary Progressive Multiple Sclerosis Secondary Progressive Multiple Sclerosis Relapsing Remitting Multiple Sclerosis Biological: ATA188 Phase 1

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Phase 1 Study to Evaluate the Safety of ATA188 in Subjects With Progressive and Relapsing-Remitting Multiple Sclerosis
Actual Study Start Date : October 19, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Progressive or RRMS
Adult subjects with either progressive forms of MS (Population A) or with Relapsing Remitting Multiple Sclerosis (Population B) will be enrolled. Subjects will be treated with ATA 188 via IV infusion.
Biological: ATA188
ATA188 is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ progressive multiple sclerosis.
Other Names:
  • Epstein-Barr Virus-directed cytotoxic T lymphocytes (CTLs)
  • EBV-CTLs
  • EBV-targeted T-cell




Primary Outcome Measures :
  1. Incidence of adverse events and clinically significant changes in laboratory tests, ECGs, and vital signs [ Time Frame: Approximately 2 years per subject ]
    Safety and tolerability

  2. Recommended Phase 2 Dose of ATA188 Monotherapy [ Time Frame: Day 1 to Day 35 of Cycle 1 for each subject in dose escalation phase (approximately 18 months) ]
    Dose finding


Secondary Outcome Measures :
  1. Change From Baseline in the Number of Gadolinium-enhancing and new or Enlarging T2 Lesions on Brain MRI Scans for Subjects With RRMS [ Time Frame: Approximately 2 years per subject ]
    Changes in MRI activity

  2. Change From Baseline in Expanded Disability Status Scale (EDSS) Score [ Time Frame: Approximately 2 years per subject ]
    Change in disability

  3. Change From Baseline in Annualized Relapse Rate (ARR) for Subjects With RRMS [ Time Frame: Approximately 2 years per subject ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 66 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Positive EBV serology
  • 18 to < 66 years of age for participants with progressive forms of MS and 18 to 45 years of age for participants with RRMS
  • History of progressive forms of MS or RRMS
  • EDSS scores of 3.0 to 7.0 for participants with progressive forms of MS (6.5 to 7.0 EDSS score must retain measurable upper limb function)
  • EDSS scores of 2.0 to 5.5 for participants with RRMS

Exclusion Criteria:

  • 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 Dose 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, cladribine, or any other immunosuppressant or cytotoxic therapy (other than steroids), antithymocyte globulin or similar anti-T cell antibody therapy
  • Any previous treatment: alemtuzumab, stem cell transplant, or EBV T-cell therapy
  • Unwilling to use protocol specified contraceptive methods
  • Women who are breastfeeding
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283826


Contacts
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Contact: Jonathan Willmer, MD 805-623-4221 clinicalstudies@atarabio.com

Locations
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United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259-5452
Contact: Jonathan Carter, MD    480-342-6675    Carter.Jonathan@mayo.edu   
United States, Louisiana
The NeuroMedical Center Clinic, PC Recruiting
Baton Rouge, Louisiana, United States, 70810-1685
Contact: April Erwin, MD    608-848-8900    aerwin@interspond.com   
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Bridget Bagert, MD    504-703-7458    bbagert@ochsner.org   
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104-5127
Contact: Amit Bar-Or, MD, FRCP, FAAN, FANA    215-220-9384    amitbar@upenn.edu   
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: John Lindsey, MD    832-325-7082    john.w.lindsey@uth.tmc.edu   
Australia, New South Wales
Liverpool Hospital Recruiting
Liverpool, New South Wales, Australia, 2170
Contact: Suzanne Hodgkinson, BSc, MB, BSFRACP, PhD    +61(2) 96164689    s.hodgkinson@unsw.edu.au   
Australia, Queensland
Royal Brisbane and Women's Hospital Recruiting
Brisbane, Queensland, Australia, 4029
Contact: Michael Pender, MD, PhD, FRACP, MBBS    +61 (7) 3365 5132    m.pender@uq.edu.au   
Griffith University, School of Medicine Recruiting
Southport, Queensland, Australia, 4222
Contact: Simon J Broadley, BSc, MBChB, PhD, FRACP    +61 (7) 567 80174    simon.broadley@griffith.edu.au   
Sponsors and Collaborators
Atara Biotherapeutics
Investigators
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Study Director: Jonathan Willmer, MD Atara Biotherapeutics

Publications:
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Responsible Party: Atara Biotherapeutics
ClinicalTrials.gov Identifier: NCT03283826     History of Changes
Other Study ID Numbers: ATA188-MS-101
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Atara Biotherapeutics:
Multiple Sclerosis (MS)
Primary Progressive Multiple Sclerosis
Secondary Progressive Multiple Sclerosis
EBV-associated Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Epstein-Barr Virus (EBV)
Inflammation
Central Nervous System
Autoimmune Disease
Autoimmunity
Demyelination
Cell Therapy
T-cell
Allogeneic
EBV viremia
Off-the-shelf (T cells)
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases