Descartes-08 CAR-T Cells in Generalized Myasthenia Gravis (MG)
August 13, 2026 updated by: Cartesian Therapeutics
Autologous T-Cells Expressing A Chimeric Antigen Receptor Directed To B-Cell Maturation Antigen (BCMA) In Patients With Generalized Myasthenia Gravis (MG)
This is a Phase IIb study to evaluate the safety and preliminary efficacy of Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
30
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alberta
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Edmonton, Alberta, Canada, T6G2C8
- University of Alberta
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California
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Carlsbad, California, United States, 92011
- Profound Research
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Irvine, California, United States, 92697
- University of California Irvine
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado Anschutz Medical Campus
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Florida
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Boca Raton, Florida, United States, 33487
- SFM Clinical Research, LLC
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Orlando, Florida, United States, 32751
- Neurology Associates, P.A.
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Tampa, Florida, United States, 33612
- University of South Florida
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Georgia
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Augusta, Georgia, United States, 30912
- University of Augusta
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center Research Institute
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New York
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Amherst, New York, United States, 14226
- Dent Neurologic Institute
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15212
- Allegheny Health Network
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Virginia
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Richmond, Virginia, United States, 23219
- Virginia Commonwealth University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Phase 1b Dose-Escalation
Generalized Myasthenia Gravis
|
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
|
|
Experimental: Phase IIa Expansion
Generalized Myasthenia Gravis
|
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
|
|
Placebo Comparator: Phase IIb Randomized Control Trial
Generalized Myasthenia Gravis
|
Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of patients with MG Composite improvement of ≥5 points.
Time Frame: Day 0 to Day 85
|
In Part 3, the primary objective is to compare the effect of Descartes-08 versus placebo, as measured by the change in MGC score from baseline to Week 12.
In Part 1, up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients; the patients will be staggered at least 21 days apart and will complete a safety review between each dose.
In Part 2, patients will receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be monitored for up to 1 year to assess the safety and tolerability of a repeated dosing schedule.
|
Day 0 to Day 85
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in titer of myasthenia specific autoantibody titers
Time Frame: Day 0 to Day 168
|
Determine the change from baseline over a period of 24 weeks in the titer of myasthenia specific autoantibody titers, e.g.
nicotinic acetylcholine receptor autoantibody (anti-nAChR) or muscle-specific tyrosine kinase autoantibody (anti- MusK or anti-Low-Density-Lipoprotein-Related-Protein4 (anti-LRP4) or anti-AChR cluster antibody and the 4 Immunoglobulin types (IgG, IgM, IgA, IgE) following single or multiple infusions of Descartes-08 in MG auto-antibody seropositive patients (Parts 1 and 2 only)
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Day 0 to Day 168
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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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Quantify the clinical effect of single or multiple infusions of Descartes-08 on patients by standard clinical assessment scales (MG ADL, QMG, MG QoL 15R, MG PIS, MG Composite) over a period of 24 weeks in MG auto-antibody seropositive and seronegative patients together and separately (all parts).
|
Day 0 to Day 168
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Comparison on Descartes-08 versus placebo on QMG and MG ADL
Time Frame: Day 0 to Day 85
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The proportion of patients achieving a ≥6-point change from Baseline at each posttreatment follow-up in the MG ADL score and QMG score (all parts), and the difference between this proportion in the treatment arm compared to placebo at Day 85.
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Day 0 to Day 85
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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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The proportion of patients initially randomized to placebo who then cross over to Descartes-08 and achieve a ≥5-point reduction in MGC score from Crossover Day 1 to Crossover Day 85. |
Day 0 to Day 85
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Fedak RR, Ruggerie RN, Shan Y, Curvino EJ, de Sousa JF, Daniel S, Ngo-Casi M, Kamboh H, Vu T, Durmus H, Mozaffar T, Howard JF Jr, English EP, Benson A, Duvernay MT, Singer MS, Kalayoglu MV, Brunn C, Bodansky A, Anderson MS, DeRisi JL, Garcia ST, Yu DJL, Zorn KC, Kurtoglu M, Miljkovic MD, Stewart CA, Jewell CM; MG-001 Study Team. BCMA-directed mRNA CAR-T cell therapy for myasthenia gravis: exploratory biomarker analysis of a placebo-controlled phase 2b trial. Nat Med. 2026 Mar;32(3):1118-1130. doi: 10.1038/s41591-025-04170-z. Epub 2026 Jan 9.
- Vu T, Durmus H, Rivner M, Shroff S, Ragole T, Myers B, Pasnoor M, Small G, Karam C, Vullaganti M, Peltier A, Sahagian G, Feinberg MH, Slanksy A, Barnett-Tapia C, Siddiqi Z, Gwathmey K, Badruddoja MA, Kamboh H, Ruggerie RN, Fedak RR, Stewart CA, Kurtoglu M, Kalayoglu M, Singer M, Jewell CM, Miljkovic MD, Dimachkie M, Mozaffar T, Howard JF Jr; MG-001 Study Team. BCMA-directed mRNA CAR T cell therapy for myasthenia gravis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2026 Mar;32(3):1131-1141. doi: 10.1038/s41591-025-04171-y. Epub 2026 Jan 9.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 4, 2019
Primary Completion (Actual)
January 5, 2026
Study Completion (Estimated)
September 30, 2026
Study Registration Dates
First Submitted
October 29, 2019
First Submitted That Met QC Criteria
October 29, 2019
First Posted (Actual)
October 31, 2019
Study Record Updates
Last Update Posted (Actual)
August 14, 2026
Last Update Submitted That Met QC Criteria
August 13, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Myasthenia Gravis
Other Study ID Numbers
- MG-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.