Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

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

Verified siteInvestigational
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

12 criteria

  • 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
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

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.

What is already known about the treatment

Descartes-08 - An investigational therapeutic agent currently undergoing Phase 3 clinical trials for the treatment of generalized myasthenia gravis, a rare autoimmune neuromuscular disorder affecting daily living activities. This medication is being evaluated through a randomized, double-blind, placebo-controlled study to assess its efficacy in improving patients' ability to perform daily activities as measured by the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale. While the specific mechanism of action and administration form are not disclosed in the trial data, the medication is being investigated as a potential new treatment option for patients with this challenging neurological condition.

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520355-25-00Protocol codeRNAC-MG-002 (AURORA)Estimated enrolment119 patientsSponsorCartesian Therapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.