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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2024 |
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Main ID: |
NCT04146051 |
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Date of registration:
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29/10/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
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Scientific title:
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Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG) |
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Date of first enrolment:
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December 4, 2019 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04146051 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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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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Study Trial Central Mailbox |
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Address:
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Telephone:
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302-648-6497 |
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Email:
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trials@cartesiantx.com |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient must be at least 18 years of age.
- Patient must have Generalized Myasthenia Gravis at the time of screening.
- Concomitant immunosuppressive drugs must be deemed necessary by the investigator.
- Seronegative Patients are included
Exclusion Criteria:
- Major chronic illness that is not well managed at the time of study entry and in the
opinion of the investigator may increase the risk to the patient.
- Patient is pregnant or lactating.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Myasthenia Gravis, Generalized
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Intervention(s)
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Drug: Descartes-08
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Primary Outcome(s)
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Myasthenia Gravis -Activities of Daily Living Score
[Time Frame: Day 0 to Day 85]
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Secondary Outcome(s)
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Comparison on Descartes-08 versus placebo on MG assessments in crossover patients
[Time Frame: Day 0 to Day 85]
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Effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales
[Time Frame: Day 0 to Day 168]
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Comparison on Descartes-08 versus placebo on QMG, MG QoL 15R, MG Composite, MG PIS
[Time Frame: Day 0 to Day 85]
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Change in titer of myasthenia specific autoantibody titers
[Time Frame: Day 0 to Day 168]
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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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