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ACTIVE NOT RECRUITINGPhase3

Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis

Sponsor: Cartesian Therapeutics

NCT ID: NCT06799247

View on ClinicalTrials.gov ↗

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.

Myasthaenia Gravis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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

test is positiveHistory of positiveor positivetuberculosis or positive

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
Inclusion Criteria: * 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 Sscreening. * 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 minimum of 8 weeks prior to Baseline visit. * If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone equivalent. The dose must have been stable for a minimum of 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 (UNL) and documented within the past 10 years of screening. * 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 highly effective birth control from Screening until 14 days post last dose of Descartes-08, Exclusion Criteria: * Major chronic illness that is not well managed at the time of study entry and in the opinion of the investigator may increase the risk to the patient. * 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. * Treatment with intravenous immunoglobulin (IVIG) or plasma exchange within 4 weeks prior to the Baseline visit. * Treatment with rituximab or ocrelizumab within 12 months prior to Baseline visit; treatment with calcineurin inhibitors (e.g. tacrolimus, cyclosporine, cyclophosphamide), Neonatal Fc receptor antagonists, and/or other biologics within 3 weeks prior to planned leukapheresis and within 8 weeks prior to Baseline visit. * The patient has started treatment with a complement 5a (C5a) inhibitor, such as eculizumab, within 8 weeks of Baseline visit. (NOTE: patients who have been receiving a C5a inhibitor for more than 8 weeks and meet other criteria for enrollment are eligible for treatment). * Prior treatment with B-cell maturation antigen (BCMA)-directed therapy (e.g. monoclonal antibody, T-cell engager, or chimeric antigen receptor T-cell \[CAR-T\]). * Abnormal prothrombin (PT)/international normalized ratio (INR) or partial thromboplastin time (PTT) increased \> 1.5-fold above the normal range at Screening or patient is on anticoagulation therapy (except in cases of elevated PTT with documented lupus anticoagulant; or in patients who have been on stable doses of anticoagulation therapy for more than 6 months of venous thromboembolism (VTE) diagnosis; or in patients on stable doses of anticoagulation therapy for at least 8 weeks of atrial fibrillation diagnosis; these conditions will not be exclusionary unless, in the investigator's opinion, they make participation in the study unsafe). * Absolute neutrophil count (ANC) \< 1000 cells/microliter. * Hemoglobin \< 8.0 g/dL. * Platelets \< 50,000/mm3. * Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \> 3x above normal. * Creatine clearance less than 30 mL/min. * History of primary immunodeficiency, organ, or allogeneic bone marrow transplant. * Patients must be seronegative for hepatitis B surface antigen. * Patients must be seronegative for hepatitis C antibody. If hepatitis C antibody test is positive, then patients must be tested for the presence of viremia by reverse transcriptase polymerase chain reaction (RT-PCR) and must be hepatitis C virus (HCV) ribonucleic acid (RNA) negative. * History of positive human immunodeficiency virus (HIV) or positive HIV at screening. * Active tuberculosis or positive QuantiFERON test at screening. * Any other clinical or laboratory abnormality that, in the opinion of the investigator, may jeopardize the subject's ability to participate in the study or could affect study outcome. * Any active significant cardiac or pulmonary disease that, in the opinion of the Principal Investigator, is significant and/or uncontrolled. Note: Patients with asthma and chronic obstructive pulmonary disease (COPD) controlled with inhaled medications are allowed. * History of malignancy that required treatment in the past 3 years, except for squamous cell carcinoma, basal cell carcinoma of the skin, or breast or early-stage colon cancer that is surgically removed and did not require adjuvant chemotherapy or radiotherapy. * Treatment with any investigational agent 4 weeks prior to screening or 5 half-lives of the investigational drug (whichever is longer). * Receipt of a live vaccination within 4 weeks prior to Baseline visit or intent to receive live vaccination during the study (Note: messenger RNA \[mRNA\]-based vaccines such as those against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are not considered live; likewise, the Janssen Covid-19 vaccine is not live). * History of significant recurrent infections or any active infection that in the opinion of the Investigator may interfere with the patient's participation in the opinion of the investigator. * Any known psychiatric illness that in the opinion of the Investigator, may interfere with the patient's participation in the study in the opinion of the investigator.

Where Is This Study? (2 UK sites)

A33

Birmingham, United Kingdom

A51

Sheffield, United Kingdom

Hospital R&D contact (matched)

Nemonie Marriott

whh.research@nhs.net01925 275513
Data sourced from ClinicalTrials.gov · Last verified: 2026-08