At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Decartes-08 (biological), Placebo Drug (other)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- Decartes-08 — biological: Autologous mRNA CAR T-cell therapy · Placebo Drug — other: infusion without Decartes-08
- Patient visit burden
- Not specified by the sponsor
In plain English
This trial is testing a therapy called Descartes-08 for adults with generalised myasthenia gravis, a condition where the immune system affects the muscles. Descartes-08 is a type of treatment called mRNA CAR T-cell therapy, which uses the patient's own immune cells that are changed in a laboratory to target the disease. The study is funded by Cartesian Therapeutics.
Who can take part
- Adults aged 18 or over
- Have generalised myasthenia gravis (grades 2-4 on the Myasthenia Gravis Foundation of America scale)
- A daily living symptom score (MG ADL) of 6 or more
- Taking immunosuppressive medicines that the doctor thinks are needed, at a stable dose for at least 8 weeks before the start
- If taking steroid tablets (like prednisone), no more than 40 mg a day, at a stable dose for at least 8 weeks before the start
- A blood test showing certain antibodies linked to myasthenia gravis, recorded in the past 10 years
- Willing and able to attend all study visits and give written consent
- Women who could become pregnant must use highly effective contraception from screening until 14 days after the last dose
Who may not be able to
- Diagnosed with generalised myasthenia gravis within the past 12 months
- Another neuromuscular disease besides myasthenia gravis
- Pregnant or breastfeeding
- Recent treatment with intravenous immunoglobulin (IVIG) or plasma exchange (within 4 weeks)
- Recent treatment with certain other medicines, including rituximab or ocrelizumab (within 12 months), or some other biologic or immunosuppressive drugs (within 3-8 weeks)
- Started a C5a inhibitor medicine (such as eculizumab) within 8 weeks — people taking it for longer may still join
- Previous treatment targeting BCMA (a protein on immune cells)
- Previous BCMA-directed CAR T-cell therapy
- Blood clotting problems or taking blood-thinning medicines, unless the doctor agrees it is safe
- Low blood counts (white cells, haemoglobin, or platelets)
- Liver blood tests more than 3 times the normal limit
- Kidney function (creatinine clearance) below 30 mL/min
- History of primary immunodeficiency, organ transplant, or bone marrow transplant from a donor
- Hepatitis B, hepatitis C (unless confirmed cleared), HIV, or tuberculosis
- Certain cancers needing treatment in the past 3 years (some treated skin, breast, and early bowel cancers are allowed)
- Another serious illness, heart or lung disease, infection, or mental health condition that the doctor thinks could affect taking part (well-controlled asthma and COPD are allowed)
- Treatment with any experimental drug recently (within 4 weeks or 5 half-lives, whichever is longer)
- A live vaccine within 4 weeks before the start, or planning one during the study (mRNA vaccines such as some COVID-19 vaccines are not live vaccines)
What taking part involves
- • Descartes-08, an mRNA CAR T-cell therapy, which uses the patient's own immune T cells changed in a laboratory to target the disease
- • Details of how the treatment is given (for example, by drip or injection), the number of doses, and the length of follow-up are not stated — ask the trial team
Time commitment: Patients must return for all study visits and use effective contraception if applicable; the number of visits, how long the study lasts, and what each visit involves are not stated — ask the trial team.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 128
- Started
- 2025-05-06
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for myasthaenia gravis
- • Phase3 - 128 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with myasthaenia gravis
Where?
- • Birmingham - A33
- • Sheffield - A51
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ been stable for a minimum of 8 weeks
What the study is looking for
- ✓Patient must be at least 18 years of age.
- ✓Patient must have generalized myasthenia gravis (gMG), Myasthenia Gravis Foundation of America (MGFA) clinical...
- ✓MG-Activities of Daily Living (MG ADL) total score ≥ 6.
- ✓Concomitant immunosuppressive drugs must be deemed necessary by the investigator. The dose must be stable for a...
- ✓If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone equivalent. The dose...
Who cannot take part
- ✗Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may...
- ✗Diagnosis of gMG within 12 months of screening.
- ✗No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.
- ✗Diagnosis of a neuromuscular disease other than gMG.
- ✗Patient is pregnant or lactating.
See the full criteria
Where Is This Study? (2 UK sites)
A33
Birmingham, United Kingdom
A51
Sheffield, United Kingdom
