Actively Recruiting
Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis
Led by Cartesian Therapeutics · Updated on 2026-03-24
100
Participants Needed
34
Research Sites
125 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The AURORA Study is evaluating the safety, tolerability, and efficacy of an investigational mRNA CAR T-cell therapy known as Descartes-08 in adults with acetylcholine receptor autoantibody -positive generalized myasthenia gravis. Part 1 of the study will last around 6 months. For eligible participants, Part 2 will last around 8 months.
CONDITIONS
Official Title
Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be at least 18 years of age.
- Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical classification grades 2-4 at the time of screening.
- MG-Activities of Daily Living (MG ADL) total score 6.
- Concomitant immunosuppressive drugs must be deemed necessary by the investigator and stable for a minimum of 8 weeks prior to Baseline visit.
- If using corticosteroids, daily dose should not exceed 40 mg/day prednisone equivalent and must be stable for at least 8 weeks prior to Baseline visit.
- Acetylcholine receptor autoantibody (anti-nAChR) titer or anti-AChR cluster antibody must be above the reference laboratory upper normal limit and documented within the past 10 years.
- Patient must be willing to return for all study visits.
- Patient must be able to give written informed consent.
- Women of childbearing potential must agree to use effective birth control from Screening until 14 days after last Descartes-08 dose.
You will not qualify if you...
- Major chronic illness not well managed that may increase risk.
- Diagnosis of gMG within 12 months of screening.
- No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
- Diagnosis of other neuromuscular diseases besides gMG.
- Patient is pregnant or lactating.
- Treatment with intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks prior to Baseline.
- Treatment with rituximab or ocrelizumab within 12 months prior to Baseline.
- Treatment with calcineurin inhibitors, Neonatal Fc receptor antagonists, or other biologics within 3 weeks prior to leukapheresis and within 8 weeks prior to Baseline.
- Started complement 5a (C5a) inhibitor therapy within 8 weeks of Baseline (patients on C5a inhibitors >8 weeks may be eligible).
- Prior treatment with B-cell maturation antigen (BCMA)-directed therapy.
- Abnormal clotting tests or on anticoagulation therapy unless stable and safe.
- Low neutrophil count (ANC < 1000 cells/microliter).
- Low hemoglobin (< 8.0 g/dL).
- Low platelets (< 50,000/mm3).
- Liver enzymes (ALT or AST) > 3 times normal.
- Creatine clearance less than 30 mL/min.
- History of primary immunodeficiency, organ or bone marrow transplant.
- Positive hepatitis B surface antigen or hepatitis C antibody with active infection.
- Positive HIV or history of HIV.
- Active tuberculosis or positive QuantiFERON test.
- Other clinical or lab abnormalities that may affect participation or outcomes.
- Significant uncontrolled cardiac or pulmonary disease (asthma and COPD controlled with inhalers allowed).
- History of recent malignancy requiring treatment except certain skin and early-stage cancers.
- Treatment with investigational agents within 4 weeks or 5 half-lives before screening.
- Receipt or intent to receive live vaccines during study (mRNA vaccines not considered live).
- History of significant recurrent or active infections.
- Psychiatric illness interfering with participation.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 34 locations
1
A40
Tucson, Arizona, United States, 85718
Actively Recruiting
2
A13
Carlsbad, California, United States, 92011
Actively Recruiting
3
A46
Los Angeles, California, United States, 90095
Actively Recruiting
4
A14
Orange, California, United States, 92868
Actively Recruiting
5
A21
Aurora, Colorado, United States, 80045
Actively Recruiting
6
A50
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
7
A48
Maitland, Florida, United States, 32751
Actively Recruiting
8
A10
Tampa, Florida, United States, 33612
Actively Recruiting
9
A53
O'Fallon, Illinois, United States, 62269
Actively Recruiting
10
A20
Fairway, Kansas, United States, 66205
Actively Recruiting
11
A16
Lexington, Kentucky, United States, 40536
Actively Recruiting
12
A38
Boston, Massachusetts, United States, 02111
Actively Recruiting
13
A12
Amherst, New York, United States, 14226
Actively Recruiting
14
A52
New York, New York, United States, 10027
Actively Recruiting
15
A47
New York, New York, United States, 10065
Actively Recruiting
16
A22
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
17
A39
Charlotte, North Carolina, United States, 28204
Actively Recruiting
18
A15
Portland, Oregon, United States, 97239
Actively Recruiting
19
A11
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
20
A49
Pittsburgh, Pennsylvania, United States, 15213
Actively Recruiting
21
A43
Houston, Texas, United States, 77030
Actively Recruiting
22
A41
Seattle, Washington, United States, 98195
Actively Recruiting
23
A54
Milwaukee, Wisconsin, United States, 53215
Actively Recruiting
24
A18
Toronto, Canada
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25
A23
Rome, Italy
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26
A30
Krakow, Poland
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27
A24
Belgrade, Serbia
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28
A25
Barcelona, Spain
Actively Recruiting
29
A26
Barcelona, Spain
Actively Recruiting
30
A31
Madrid, Spain
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31
A32
Ankara, Turkey (Türkiye)
Actively Recruiting
32
A17
Istanbul, Turkey (Türkiye)
Actively Recruiting
33
A33
Birmingham, United Kingdom
Actively Recruiting
34
A51
Sheffield, United Kingdom
Actively Recruiting
Research Team
C
Cartesian Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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