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Could a One-Time cell therapy ease myasthenia gravis? new trial launches

NCT ID NCT06799247

Disease control Sponsor: Cartesian Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This phase 3 study tests an experimental treatment called Descartes-08 for adults with generalized myasthenia gravis, a condition causing muscle weakness. The therapy uses modified immune cells (mRNA CAR T-cells) to target the disease. About 100 participants will receive either the treatment or a placebo, and researchers will measure improvements in daily activities over 4 months. Participants must be on stable immunosuppressive medications, meaning this is not a cure but aims to better control the disease.

Why investors are watching

Cartesian Therapeutics is running a phase 3 trial of Descartes-08, an mRNA CAR T-cell therapy, in people with generalized myasthenia gravis. The trial compares the treatment against a placebo in 128 adults whose condition is tied to acetylcholine receptor antibodies. For a small company, this readout is a major test of whether its lead product works in a larger, controlled setting.

If it works: A positive result could position Descartes-08 as a potential new option for a chronic autoimmune disease, giving Cartesian a path toward regulatory approval and its first commercial product. That outcome would validate the company's core technology platform.

If it fails: Phase 3 trials often fail even after earlier promise, and a negative or delayed result could set the program back years. For a small company with few other assets, such a setback would be hard to absorb.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

128 people

The number who actually took part.

Started

May 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myasthaenia gravis

Contacts and locations

Locations

  • A10

    Tampa, Florida, 33612, United States

  • A11

    Philadelphia, Pennsylvania, 19104, United States

  • A12

    Amherst, New York, 14226, United States

  • A13

    Carlsbad, California, 92011, United States

  • A14

    Orange, California, 92868, United States

  • A15

    Portland, Oregon, 97239, United States

  • A16

    Lexington, Kentucky, 40536, United States

  • A17

    Istanbul, Turkey (Türkiye)

  • A18

    Toronto, Canada

  • A20

    Fairway, Kansas, 66205, United States

  • A21

    Aurora, Colorado, 80045, United States

  • A22

    Chapel Hill, North Carolina, 27599, United States

  • A23

    Rome, Italy

  • A24

    Belgrade, Serbia

  • A25

    Barcelona, Spain

  • A26

    Barcelona, Spain

  • A30

    Krakow, Poland

  • A31

    Madrid, Spain

  • A32

    Ankara, Turkey (Türkiye)

  • A33

    Birmingham, United Kingdom

  • A38

    Boston, Massachusetts, 02111, United States

  • A39

    Charlotte, North Carolina, 28204, United States

  • A40

    Tucson, Arizona, 85718, United States

  • A41

    Seattle, Washington, 98195, United States

  • A43

    Houston, Texas, 77030, United States

  • A46

    Los Angeles, California, 90095, United States

  • A47

    New York, New York, 10065, United States

  • A48

    Maitland, Florida, 32751, United States

  • A49

    Pittsburgh, Pennsylvania, 15213, United States

  • A50

    Washington D.C., District of Columbia, 20007, United States

  • A51

    Sheffield, United Kingdom

  • A52

    New York, New York, 10027, United States

  • A53

    O'Fallon, Illinois, 62269, United States

  • A54

    Milwaukee, Wisconsin, 53215, United States

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