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

Primary Purpose

Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ATA188
Placebo
Sponsored by
Atara Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Multiple Sclerosis focused on measuring Multiple Sclerosis (MS), Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Epstein-Barr Virus (EBV), EBV-associated Multiple Sclerosis, Inflammation, Central Nervous System, Autoimmune Disease, Autoimmunity, Demyelination, Cell Therapy, T-cell, Allogeneic, EBV viremia, Off-the-shelf (T cells)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • For Part 1: History of progressive forms of MS (PPMS or SPMS), as defined by the 2010 Revised McDonald criteria for the diagnosis of MS
  • For Part 1: 18 to < 66 years of age
  • For Part 1: EDSS scores of 3.0 to 7.0. Participants with EDSS scores of 6.5 to 7.0 must retain measurable upper limb function as assessed by the 9-hole Peg Test (9HPT).
  • For Part 2: Current diagnosis of a progressive form of MS (PPMS or SPMS) as defined by the 2017 Revised McDonald criteria
  • For Part 2:18 to < 61 years of age
  • For Part 2:EDSS scores of 3.0 to 6.5
  • Positive EBV serology
  • Willing and able to provide written informed consent

Exclusion Criteria:

  • Clinical relapse as follows: For Part 1: Active clinical relapse between providing informed consent and the first dose of study drug. 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.)
  • Concurrent serious uncontrolled or unresolved medical condition, such as infection, limiting protocol compliance or exposing the subject to unacceptable risk
  • 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
  • For Part 1: Positive serology for syphilis or human T cell lymphotrophic virus I/II
  • Uncontrolled psychosis, uncontrolled depression or suicide risk, substance dependence, or any other psychiatric condition that may compromise the ability to participate in this trial
  • 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)
  • Any history of cancer (as exceptions, successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix with a < 5% chance of recurrence within 12 months of providing informed consent are allowed.)
  • Prior therapy with corticosteroids (within 2 weeks before Cycle 1 Day 1)
  • Prior therapy (30 days) B-cell depleting agent (eg, anti-CD20 agents such as ocrelizumab); participant must be progressing despite therapy to be eligible
  • For Part 1: Prior therapy (6 half-lives or 30 days whichever is longer) with cladribine, glatiramer acetate, interferon β, dimethyl fumarate, 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 Part 1: Any previous treatment with alemtuzumab, ablative stem cell transplant, or EBV T-cell therapy
  • For Part 2: Prior therapy (6 half-lives or 30 days whichever is longer) with IV immunoglobin, plasmapheresis, Bruton's tyrosine kinase inhibitors, all sphingosine 1-phosphate receptor modulators (eg, fingolimod), glatiramer acetate, interferon β, nuclear factor (erythroid-derived 2)-like 2 (Nrf2) activators (eg, dimethyl fumarate), methotrexate, azathioprine, cyclosporine, 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 Part 2: Any previous treatment with cladribine, alemtuzumab, ablative stem cell transplant, or EBV T-cell therapy
  • Unresolved reactions from previous therapies that may, in the investigator's opinion, impact the safety of the participant or the conduct of this study
  • Unwilling to use protocol specified contraceptive methods
  • Women who are breastfeeding
  • Pregnancy
  • Inability or unwillingness to comply with study procedures

Sites / Locations

  • University of California, San Diego
  • Kaiser Permanente MS Clinic Los Angeles
  • Stanford University
  • University of California San Francisco
  • University of Colorado
  • Advanced Neurology
  • Neurology Associates, PA-Maitland
  • University of South Florida, Morsani College of Medicine
  • Fort Wayne Neurological Center
  • University of Kansas Medical Center KUMC - Multiple Sclerosis MS Center
  • Ochsner Clinic Foundation
  • Dragonfly Research
  • Washington University in St. Louis
  • Dent Neurologic Institute
  • Columbia University Medical Center-The Neurological Institute of New York
  • University of Rochester Medical Center - URMC
  • PMG Research of Piedmont Healthcare
  • University of Pennsylvania
  • Premier Neurology P.C.
  • Advanced Neurosciences Institute ANI - Franklin
  • Vanderbilt Comprehensive Multiple Sclerosis Center
  • The University of Texas Health Science Center at Houston
  • MS Center of Greater Washington
  • Inland Northwest Research LLC
  • Medical College of Wisconsin
  • Liverpool Hospital
  • Royal Brisbane and Women's Hospital
  • Griffith University, School of Medicine
  • Fraser Health Multiple Sclerosis Clinic
  • Unity Health Toronto/St. Michael's Hospital
  • Recherche Sepmus Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ATA188

Placebo

Arm Description

Participants in Parts 1 and 2 will receive ATA188 intravenously as described in the Detailed Description.

Participants in Part 2 will receive placebo matching to ATA188 intravenously as described in the Detailed Description (i.e., will receive placebo only in the first year, and thereafter will receive ATA188 for the remainder of the study).

Outcomes

Primary Outcome Measures

Part 1: Incidence of adverse events
Part 1: Incidence of clinically significant changes in laboratory tests, electrocardiograms (ECGs), and vital signs
Part 1: Recommended Part 2 dose of ATA188 monotherapy
Part 2: Percentage of participants with confirmed expanded disability status scale (EDSS) improvement at 12 months

Secondary Outcome Measures

Part 1: Change from baseline in EDSS score
Part 2: Percentage of participants with confirmed EDSS improvement at 15 months
Part 2: Percentage of participants with sustained disability improvement (SDI; ie, confirmed EDSS improvement or 20% decrease in timed 25-foot walk [T25W]) at 12 months
Part 2: Percentage of participants with SDI at 15 months
Part 2: Change from baseline in immunoglobulin G (IgG) index

Full Information

First Posted
September 13, 2017
Last Updated
April 24, 2023
Sponsor
Atara Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03283826
Brief Title
Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
Acronym
EMBOLD
Official Title
A Phase 1/2, 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atara Biotherapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 clinical disability, as assessed by confirmed Expanded Disability Status Scale (EDSS) improvement at 12 months in Part 2 in participants with progressive forms of multiple sclerosis (MS) (primary progressive multiple sclerosis [PPMS] and secondary progressive multiple sclerosis [SPMS]).
Detailed Description
This is a multicenter, 2 part study in adult participants with progressive forms of MS (PPMS/SPMS) with an open-label, single-arm, sequential dose-escalation period (Part 1) and a double-blind, randomized, placebo-controlled dose-expansion period (Part 2) followed by open-label extension (OLE) period. Part 2 and the OLE have been initiated by the sponsor's discretion based on a review of data from the dose-escalation cohorts. This study will evaluate the safety and efficacy of ATA188 administered by intravenous (IV) infusion. ATA188 will be selected for each participant based on matching 2 or more human leukocyte antigen (HLA) alleles shared between ATA188 and the participant, at least 1 of which is a HLA-restricting allele. In Part 1, participants received 2 cycles of ATA188 and entered 12 months follow-up period after the last dose of ATA188. Participants who completed at least the first year of the dose-escalation period and were active in the study have entered the OLE period. In OLE period, participants will receive the same RP2D assigned to Part 2 participants at the time of the Part 1 participant's first dose in each year of the OLE. In OLE period, participants will receive 1 cycle of ATA188 treatment every 12 months (Q12M) for up to 4 years (ie, Years 2 to 5). Otherwise, end of study (EOS) visit will be conducted at 24 months after Cycle 1 Day 1. In Part 2, participants will be randomized in 1:1 ratio to receive ATA188 at the RP2D or matching placebo, stratified by progressive MS diagnosis (PPMS vs SPMS) and any prior exposure to anti-CD20 therapy (yes vs no). Participants will receive 2 cycles of ATA188 at the RP2D or matching placebo and will be followed for at least 12 months after the first dose of study drug (ie, Year 1). In second year (Year 2), participants who received placebo in Year 1 will receive 2 cycles of ATA188 at the RP2D assigned at randomization and participants who received ATA188 at the RP2D in Year 1 will receive 1 cycle of ATA188 (at the RP2D assigned at randomization) and 1 cycle of placebo to maintain the blind. Participants who complete Year 2 will enter the OLE period to receive ATA188 Q12M for up to 3 years (ie, Years 3 to 5) at the RP2D that was last selected by the sponsor for Part 2. The end of study visit will be scheduled at 5 years (60 months) after the first dose of study drug (ie, Cycle 1 Day 1). Based on interim analysis, the recruitment for Parts 1and 2 have completed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Keywords
Multiple Sclerosis (MS), Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis, Epstein-Barr Virus (EBV), EBV-associated Multiple Sclerosis, Inflammation, Central Nervous System, Autoimmune Disease, Autoimmunity, Demyelination, Cell Therapy, T-cell, Allogeneic, EBV viremia, Off-the-shelf (T cells)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ATA188
Arm Type
Experimental
Arm Description
Participants in Parts 1 and 2 will receive ATA188 intravenously as described in the Detailed Description.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants in Part 2 will receive placebo matching to ATA188 intravenously as described in the Detailed Description (i.e., will receive placebo only in the first year, and thereafter will receive ATA188 for the remainder of the study).
Intervention Type
Biological
Intervention Name(s)
ATA188
Other Intervention Name(s)
Epstein-Barr Virus-directed cytotoxic T lymphocytes (CTLs), EBV-CTLs, EBV-targeted T-cell
Intervention Description
ATA188 is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ progressive multiple sclerosis.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo matching to ATA188
Primary Outcome Measure Information:
Title
Part 1: Incidence of adverse events
Time Frame
At 12 months after the first dose of study drug
Title
Part 1: Incidence of clinically significant changes in laboratory tests, electrocardiograms (ECGs), and vital signs
Time Frame
At 12 months after the first dose of study drug
Title
Part 1: Recommended Part 2 dose of ATA188 monotherapy
Time Frame
Day 1 to Day 35 of Cycle 1 for each participant in dose escalation part (approximately 1 year)
Title
Part 2: Percentage of participants with confirmed expanded disability status scale (EDSS) improvement at 12 months
Time Frame
At 12 months after the first dose of study drug
Secondary Outcome Measure Information:
Title
Part 1: Change from baseline in EDSS score
Time Frame
At 12 months after the first dose of study drug
Title
Part 2: Percentage of participants with confirmed EDSS improvement at 15 months
Time Frame
At 15 months after the first dose of study drug
Title
Part 2: Percentage of participants with sustained disability improvement (SDI; ie, confirmed EDSS improvement or 20% decrease in timed 25-foot walk [T25W]) at 12 months
Time Frame
At 12 months after the first dose of study drug
Title
Part 2: Percentage of participants with SDI at 15 months
Time Frame
At 15 months after the first dose of study drug
Title
Part 2: Change from baseline in immunoglobulin G (IgG) index
Time Frame
At 9 months after the first dose of study drug
Other Pre-specified Outcome Measures:
Title
Change from baseline in cervical spinal cord volume on MRI scans
Time Frame
At 12 months after the first dose of study drug
Title
Change from baseline in whole brain volume on MRI scans
Time Frame
At 12 months after the first dose of study drug
Title
Change from baseline in number of Gd-enhancing and new or enlarging T2 lesions on brain MRI scans
Time Frame
At 12 months after the first dose of study drug
Title
Change from baseline in IgG production
Time Frame
At 12 months after the first dose of study drug

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: For Part 1: History of progressive forms of MS (PPMS or SPMS), as defined by the 2010 Revised McDonald criteria for the diagnosis of MS For Part 1: 18 to < 66 years of age For Part 1: EDSS scores of 3.0 to 7.0. Participants with EDSS scores of 6.5 to 7.0 must retain measurable upper limb function as assessed by the 9-hole Peg Test (9HPT). For Part 2: Current diagnosis of a progressive form of MS (PPMS or SPMS) as defined by the 2017 Revised McDonald criteria For Part 2:18 to < 61 years of age For Part 2:EDSS scores of 3.0 to 6.5 Positive EBV serology Willing and able to provide written informed consent Exclusion Criteria: Clinical relapse as follows: For Part 1: Active clinical relapse between providing informed consent and the first dose of study drug. 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.) Concurrent serious uncontrolled or unresolved medical condition, such as infection, limiting protocol compliance or exposing the subject to unacceptable risk 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 For Part 1: Positive serology for syphilis or human T cell lymphotrophic virus I/II Uncontrolled psychosis, uncontrolled depression or suicide risk, substance dependence, or any other psychiatric condition that may compromise the ability to participate in this trial 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) Any history of cancer (as exceptions, successfully treated non-melanoma skin cancer or carcinoma in situ of the cervix with a < 5% chance of recurrence within 12 months of providing informed consent are allowed.) Prior therapy with corticosteroids (within 2 weeks before Cycle 1 Day 1) Prior therapy (30 days) B-cell depleting agent (eg, anti-CD20 agents such as ocrelizumab); participant must be progressing despite therapy to be eligible For Part 1: Prior therapy (6 half-lives or 30 days whichever is longer) with cladribine, glatiramer acetate, interferon β, dimethyl fumarate, 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 Part 1: Any previous treatment with alemtuzumab, ablative stem cell transplant, or EBV T-cell therapy For Part 2: Prior therapy (6 half-lives or 30 days whichever is longer) with IV immunoglobin, plasmapheresis, Bruton's tyrosine kinase inhibitors, all sphingosine 1-phosphate receptor modulators (eg, fingolimod), glatiramer acetate, interferon β, nuclear factor (erythroid-derived 2)-like 2 (Nrf2) activators (eg, dimethyl fumarate), methotrexate, azathioprine, cyclosporine, 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 Part 2: Any previous treatment with cladribine, alemtuzumab, ablative stem cell transplant, or EBV T-cell therapy Unresolved reactions from previous therapies that may, in the investigator's opinion, impact the safety of the participant or the conduct of this study Unwilling to use protocol specified contraceptive methods Women who are breastfeeding Pregnancy Inability or unwillingness to comply with study procedures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kiren Kresa-Reahl, MD
Organizational Affiliation
Atara Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Kaiser Permanente MS Clinic Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Advanced Neurology
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Neurology Associates, PA-Maitland
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of South Florida, Morsani College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Fort Wayne Neurological Center
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
University of Kansas Medical Center KUMC - Multiple Sclerosis MS Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Dragonfly Research
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dent Neurologic Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
Columbia University Medical Center-The Neurological Institute of New York
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Rochester Medical Center - URMC
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
PMG Research of Piedmont Healthcare
City
Mooresville
State/Province
North Carolina
ZIP/Postal Code
28117
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-5127
Country
United States
Facility Name
Premier Neurology P.C.
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Advanced Neurosciences Institute ANI - Franklin
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt Comprehensive Multiple Sclerosis Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
MS Center of Greater Washington
City
Vienna
State/Province
Virginia
ZIP/Postal Code
22182
Country
United States
Facility Name
Inland Northwest Research LLC
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Griffith University, School of Medicine
City
Southport
State/Province
Queensland
ZIP/Postal Code
4222
Country
Australia
Facility Name
Fraser Health Multiple Sclerosis Clinic
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
Unity Health Toronto/St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V2J2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24493474
Citation
Pender MP, Csurhes PA, Smith C, Beagley L, Hooper KD, Raj M, Coulthard A, Burrows SR, Khanna R. Epstein-Barr virus-specific adoptive immunotherapy for progressive multiple sclerosis. Mult Scler. 2014 Oct;20(11):1541-4. doi: 10.1177/1352458514521888. Epub 2014 Feb 3.
Results Reference
background
PubMed Identifier
28197337
Citation
Pender MP, Csurhes PA, Burrows JM, Burrows SR. Defective T-cell control of Epstein-Barr virus infection in multiple sclerosis. Clin Transl Immunology. 2017 Jan 20;6(1):e126. doi: 10.1038/cti.2016.87. eCollection 2017 Jan. Erratum In: Clin Transl Immunology. 2017 Jun 16;6(6):e147.
Results Reference
background

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

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