Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
NCT ID: NCT04146051
Last Updated: 2025-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2019-12-04
2026-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Phase 1b Dose-Escalation
Generalized Myasthenia Gravis
Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Phase IIa Expansion
Generalized Myasthenia Gravis
Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Phase IIb Randomized Control Trial
Generalized Myasthenia Gravis
Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Interventions
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Descartes-08
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient is pregnant or lactating.
18 Years
ALL
No
Sponsors
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Cartesian Therapeutics
INDUSTRY
Responsible Party
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Locations
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Profound Research
Carlsbad, California, United States
University of California Irvine
Irvine, California, United States
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
SFM Clinical Research, LLC
Boca Raton, Florida, United States
Neurology Associates, P.A.
Orlando, Florida, United States
University of South Florida
Tampa, Florida, United States
University of Augusta
Augusta, Georgia, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Dent Neurologic Institute
Amherst, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Allegheny Health Network
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
University of Alberta
Edmonton, Alberta, Canada
Countries
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References
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Granit V, Benatar M, Kurtoglu M, Miljkovic MD, Chahin N, Sahagian G, Feinberg MH, Slansky A, Vu T, Jewell CM, Singer MS, Kalayoglu MV, Howard JF Jr, Mozaffar T; MG-001 Study Team. Safety and clinical activity of autologous RNA chimeric antigen receptor T-cell therapy in myasthenia gravis (MG-001): a prospective, multicentre, open-label, non-randomised phase 1b/2a study. Lancet Neurol. 2023 Jul;22(7):578-590. doi: 10.1016/S1474-4422(23)00194-1.
Meisel A. Are CAR T cells the answer to myasthenia gravis therapy? Lancet Neurol. 2023 Jul;22(7):545-546. doi: 10.1016/S1474-4422(23)00211-9. No abstract available.
Other Identifiers
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MG-001
Identifier Type: -
Identifier Source: org_study_id
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