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Study of Descartes-08 compared to placebo in adults with generalized myasthenia gravis

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What is this study about?

This study focuses on Generalized Myasthenia Gravis, a rare autoimmune disease that causes muscle weakness and fatigue affecting daily activities. The investigation examines a new treatment called Descartes-08, which consists of modified immune cells (specifically CD8+ T lymphocytes) that have been engineered to target specific proteins involved in the disease process.

The research aims to determine if Descartes-08 can improve the ability to perform daily activities in people with Generalized Myasthenia Gravis. The treatment is administered through intravenous infusion, and participants will receive either Descartes-08 or placebo. The study will monitor patients for 4 months to assess changes in their symptoms and ability to perform everyday tasks.

The medication being tested is a type of cell therapy that uses the patient’s own immune cells that have been modified in a laboratory. These cells are specifically designed to target and fight the mechanisms causing muscle weakness in Generalized Myasthenia Gravis. Throughout the study, participants will undergo regular evaluations to measure their muscle strength and daily functioning abilities.

1 Initial qualification

You must be at least 18 years old and diagnosed with generalized myasthenia gravis (gMG) with clinical classification grades II-IV.

Your MG-Activities of Daily Living (MG-ADL) total score needs to be 6 or higher.

You must have positive acetylcholine receptor antibody test results documented within the past 10 years.

2 Medication requirements

If you are taking immunosuppressive medications, the dose must be stable for at least 8 weeks before starting the trial.

If you are using corticosteroids, your daily dose should not exceed 40 mg/day of prednisone (or equivalent), with a stable dose for at least 8 weeks before starting.

3 Treatment period

You will receive either Descartes-08 or a placebo through intravenous administration.

The treatment period will last for 4 months.

Regular evaluations will occur at months 2, 3, and 4 to measure changes in your condition.

4 Monitoring and assessments

Your daily living activities will be monitored using the MG-ADL score.

Additional assessments will include MGC (Myasthenia Gravis Composite) and QMG (Quantitative Myasthenia Gravis) scores.

The main goal is to achieve at least a 3-point improvement in the MG-ADL score by month 4.

5 Safety requirements

If you are a woman who can become pregnant, you must use effective birth control during the study and for 14 days after the last dose.

Regular attendance at all scheduled study visits is required for monitoring your health and progress.

Who Can Join the Study?

  • Must be 18 years or older
  • Must have confirmed generalized myasthenia gravis (a condition that causes muscle weakness) with severity grades II-IV
  • Must have a score of 6 or higher on the MG-Activities of Daily Living scale (a test that measures how the disease affects daily activities)
  • Must be taking immunosuppressive medications (drugs that reduce immune system activity) at a stable dose for at least 8 weeks before starting the study
  • If taking corticosteroids (like prednisone), the daily dose must not exceed 40 mg per day and must be stable for at least 8 weeks before starting the study
  • Must have positive blood test results for acetylcholine receptor antibodies (proteins that indicate the presence of myasthenia gravis) documented within the past 10 years
  • Must be willing to attend all required study visits
  • Must be able to provide written informed consent
  • Women who can become pregnant must agree to use effective birth control during the study and for 14 days after the last dose of the study medication

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Pregnant or breastfeeding women
  • Patients with severe myasthenia gravis requiring mechanical ventilation
  • Patients who have received any investigational treatment within 30 days before the study
  • History of allergic reactions to similar treatments
  • Active infections or serious medical conditions that could interfere with the study
  • Patients who cannot comply with study procedures or follow-up visits
  • People with compromised immune systems or taking medications that suppress the immune system
  • Patients with significant heart, liver, or kidney disease
  • Those who have had major surgery within 3 months before the study
  • Patients currently participating in other clinical trials
  • History of drug or alcohol abuse within the past year

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Azienda Ospedaliera Universitaria Federico II Di Napoli Naples Italy
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Sjxkzpnufuj Ptssvkqql Sbcllvr Kvgiwqwys Np 1 Ivtrdbmgeukjglpobm Sxievvp Swgzorwbu Ulwavnvvrmyo Mtscvzrpvh W Kckqylhugb Zabrze Poland
Nrilgolh Isaptice Osyyybaus Ijy Mrrbi Subvshoyurcknngxfoaebxafzoad Iiulfwdb Bfmkjung Cracow Poland
Hsdqyjav Dq Ln Scytz Capj I Szuc Pdv Barcelona Spain
Flwjbzmtx Plzk Lj Ivtbqgzlyhbvb Bbituvvkq Djf Hlydhdmo Ugrunchrvhjcb Lr Pdl Madrid Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
15.07.2025
Poland Poland
Recruiting
15.07.2025
Spain Spain
Recruiting
15.07.2025

Trial locations

Descartes-08 is an investigational therapy being studied for the treatment of generalized myasthenia gravis, a rare autoimmune disease that causes muscle weakness. This medication is designed to help improve daily activities and function in patients with myasthenia gravis. The therapy aims to reduce the severity of symptoms that affect everyday tasks like speaking, swallowing, and moving.

Investigated diseases:

Generalized Myasthenia Gravis – A rare autoimmune disorder that causes muscle weakness and fatigue throughout the body. The condition occurs when the immune system mistakenly attacks the connection between nerves and muscles, specifically targeting the acetylcholine receptors at the neuromuscular junction. The weakness typically worsens with activity and improves with rest, affecting multiple muscle groups including those controlling eye movements, facial expressions, chewing, swallowing, and limb movements. The disease can develop at any age and tends to progress gradually, with symptoms varying in severity from person to person. The term “generalized” means that multiple muscle groups throughout the body are affected, rather than just specific areas.

Trial ID:
2024-520355-25-00
Protocol code:
RNAC-MG-002 (AURORA)
NCT ID:
NCT06799247
Trial Phase:
Therapeutic confirmatory (Phase III)

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