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CAR T-cell Therapy
Descartes-08 for Myasthenia Gravis
Tampa, FL
Phase 3
Waitlist Available
Research Sponsored by Cartesian Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of screening.
Patient must be at least 18 years of age.
Must not have
Creatine clearance less than 30 mL/min.
History of primary immunodeficiency, organ, or allogeneic bone marrow transplant.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessment at 4 months of study
Awards & highlights
Pivotal Trial
Summary
This trial is testing a new type of gene therapy called Descartes-08 in adults with a specific type of muscle disease called myasthenia gravis. The first part of the study will
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Who is the study for?
Adults with generalized myasthenia gravis who test positive for acetylcholine receptor autoantibodies can join this trial. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.Check my eligibility
What is being tested?
The AURORA Study is testing Descartes-08, an experimental mRNA CAR T-cell therapy against a placebo to see if it's safe and works for treating myasthenia gravis. The first part of the study lasts about 6 months, followed by an optional second part lasting approximately 8 months.See study design
What are the potential side effects?
While specific side effects are not listed here, mRNA CAR T-cell therapies like Descartes-08 can sometimes cause immune reactions, infusion-related symptoms, fatigue, or other unforeseen issues due to their novel nature.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My myasthenia gravis is moderate to severe.
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I am 18 years old or older.
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My daily activities are significantly affected by my condition.
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My tests show high levels of acetylcholine receptor antibodies.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced with a creatinine clearance below 30 mL/min.
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I have had a transplant or have a primary immune deficiency.
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I have only used acetylcholine esterase inhibitors for my gMG.
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I have a neuromuscular condition that is not generalized Myasthenia Gravis.
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I have not had IVIG or plasma exchange in the last 4 weeks.
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I have previously received BCMA-targeted therapy.
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I do not have hepatitis C or my test shows no active virus.
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I have active tuberculosis or a positive TB test.
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I am HIV positive.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessment at 4 months of study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessment at 4 months of study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Myasthenia Gravis Activities of Daily Living (MG-ADL)
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Decartes-08Experimental Treatment1 Intervention
This group will undergo leukapheresis and receive manufactured Decartes-08
Group II: PlaceboPlacebo Group1 Intervention
This group will receive placebo
Find a Location
Closest Location:USF· Tampa, FL
Who is running the clinical trial?
Cartesian TherapeuticsLead Sponsor
9 Previous Clinical Trials
197 Total Patients Enrolled
1 Trials studying Myasthenia Gravis
30 Patients Enrolled for Myasthenia Gravis