Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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4 March 2024 |
Main ID: |
NCT03283826 |
Date of registration:
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13/09/2017 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Phase 1/2 Study to Evaluate the Safety and Efficacy of ATA188 in Subjects With Progressive Multiple Sclerosis
EMBOLD |
Scientific title:
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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 |
Date of first enrolment:
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October 19, 2017 |
Target sample size:
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134 |
Recruitment status: |
Terminated |
URL:
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https://clinicaltrials.gov/ct2/show/NCT03283826 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Australia
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Canada
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United States
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Contacts
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Name:
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Kiren Kresa-Reahl, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Atara Biotherapeutics |
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Key inclusion & exclusion criteria
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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 ß, 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 ß,
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
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Progressive Multiple Sclerosis
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Secondary Progressive Multiple Sclerosis
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Intervention(s)
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Drug: Placebo
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Biological: ATA188
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Primary Outcome(s)
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Part 1: Incidence of adverse events
[Time Frame: At 12 months after the first dose of study drug]
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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)]
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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]
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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]
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Secondary Outcome(s)
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Part 2: Change from baseline in immunoglobulin G (IgG) index
[Time Frame: At 9 months after the first dose of study drug]
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Part 1: Change from baseline in EDSS score
[Time Frame: At 12 months after the first dose of study drug]
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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]
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Part 2: Percentage of participants with confirmed EDSS improvement at 15 months
[Time Frame: At 15 months after the first dose of study drug]
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Part 2: Percentage of participants with SDI at 15 months
[Time Frame: At 15 months after the first dose of study drug]
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Secondary ID(s)
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ATA188-MS-101
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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