Myasthaenia GravisPhase 3NCT06799247
Investigating an mRNA CAR T-cell Therapy, Known as Descartes-08, as a Potential Approach to Treat Myasthenia Gravis
A Phase 3 study testing Decartes-08 in people with Myasthaenia Gravis, run by Cartesian Therapeutics at 34 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myasthaenia Gravis
- What is being tested?
- Decartes-08
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 34 sitesin 8 countries
- Study dates
- 6 May 2025to 30 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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,
Who cannot join
- 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.
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- 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.
Trial locations and contacts
34 sites in 8 countries.
34 sites in 8 countries
United States23 sites
A12
Amherst, New York, 14226
A21
Aurora, Colorado, 80045
A38
Boston, Massachusetts, 02111
A13
Carlsbad, California, 92011
A22
Chapel Hill, North Carolina, 27599
A39
Charlotte, North Carolina, 28204
A20
Fairway, Kansas, 66205
A43
Houston, Texas, 77030
A16
Lexington, Kentucky, 40536
A46
Los Angeles, California, 90095
A48
Maitland, Florida, 32751
A54
Milwaukee, Wisconsin, 53215
A52
New York, New York, 10027
A47
New York, New York, 10065
A53
O'Fallon, Illinois, 62269
A14
Orange, California, 92868
A11
Philadelphia, Pennsylvania, 19104
A49
Pittsburgh, Pennsylvania, 15213
A15
Portland, Oregon, 97239
A41
Seattle, Washington, 98195
A10
Tampa, Florida, 33612
A40
Tucson, Arizona, 85718
A50
Washington D.C., District of Columbia, 20007
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
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
- Myasthaenia Gravis
- Being tested
- Decartes-08, Placebo Drug
- Keywords
- myasthenia gravis, CAR-T therapy, Cell Therapy, Decartes-8, BMCA, B cell maturation antigen
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decartes-08Biological
Autologous mRNA CAR T-cell therapy
Placebo DrugOther
infusion without Decartes-08
| Study group | Role | What they receive |
|---|---|---|
| Decartes-08 | Experimental | This group will undergo leukapheresis and receive manufactured Decartes-08 Receives: Biological: Decartes-08 |
| Placebo | Placebo comparator | This group will receive placebo Receives: Other: Placebo Drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myasthenia Gravis Activities of Daily Living (MG-ADL)
To evaluate the efficacy of Descartes-08 as assessed by the proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders at Month 4.
Measured: assessment at 4 months of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start6 May 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthaenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized, double-blind, placebo-controlled, multi-center phase 3 trial to evaluate the efficacy, safety and tolerability of autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with antibody positive gMG. The cell product will be referred to as "Descartes-08".
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cartesian Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799247
- Sponsor's protocol ID
- RNAC-MG-002 (AURORA)
- Status last verified
- Aug 2026
- First submitted
- 23 Jan 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial of Descartes-08 in Patients With Generalized Myasthenia Gravis (MG)
- ClinicalTrials.gov ID
- NCT06799247
- Acronym / sponsor ID
- RNAC-MG-002 (AURORA)
- Conditions
- Myasthaenia Gravis
- Keywords
- myasthenia gravis, CAR-T therapy, Cell Therapy, Decartes-8, BMCA, B cell maturation antigen
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Cartesian TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 6 May 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, placebo-controlled, multi-center phase 3 trial to evaluate the efficacy, safety and tolerability of autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with antibody positive gMG. The cell product will be referred to as "Descartes-08".
| Arm | Type | Receives |
|---|---|---|
| Decartes-08 | Experimental | Biological: Decartes-08This group will undergo leukapheresis and receive manufactured Decartes-08 |
| Placebo | Placebo comparator | Other: Placebo DrugThis group will receive placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (28 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decartes-08Autologous mRNA CAR T-cell therapy | Biological | Decartes-08 |
| Placebo Druginfusion without Decartes-08 | Other | Placebo |
Primary outcome
Myasthenia Gravis Activities of Daily Living (MG-ADL)
Time frame: assessment at 4 months of study
To evaluate the efficacy of Descartes-08 as assessed by the proportion of Myasthenia Gravis Activities of Daily Living (MG-ADL) responders at Month 4.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
34 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Decartes-08 in people with Myasthaenia Gravis, run by Cartesian Therapeutics at 34 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 sites in United States, Spain, Turkey (Türkiye), United Kingdom, Canada and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myasthenia Gravis Activities of Daily Living (MG-ADL) (time frame: assessment at 4 months of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.