DESCARTES-08 for Generalized myasthenia gravis|Myasthenia gravis|AChR myasthenia gravis

Inclusion criteria

• {"criterion_text":"- Patient must be at least 18 years of age.\n- Patient must have gMG, MGFA clinical classification grades II-IV at Screening.\n- MG-Activities of Daily Living (MG ADL) total score ≥ 6\n- Concomitant immunosuppressive drugs must be deemed necessary by the Investigator. The patient must be on a stable dose for a minimum of 8 weeks prior to Baseline visit.\n- If a patient is using corticosteroids, the daily dose should not exceed 40 mg/day of prednisone (or equivalent). The dose must be stable for a minimum of 8 weeks prior to Baseline visit.\n- 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.\n- Patient must be willing to return for all study visits.\n- Patient must be able to provide written informed consent.\n- 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

• {"criterion_text":"- Major chronic illness that is not well managed at the time of study entry and in the opinion of the Investigator, may increase the safety risk to the patient.\n- Abnormal PT/INR or PTT increased > 1.5-fold above the normal range at Screening or the 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 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).\n- ANC < 1000 cells/microliter\n- Hemoglobin < 8.0 g/dL\n- Platelets: < 50,000/mm at screening\n- Creatinine Clearance < 30 mL/min at Screening\n- History of primary immunodeficiency, organ, or allogeneic bone marrow transplant\n- Diagnosis of gMG within 12 months of Screening.\n- No history of systemic treatment for gMG other than acetylcholine esterase inhibitors.\n- Diagnosis of a neuromuscular disease other than gMG.\n- Patient is pregnant or lactating.\n- Treatment with IVIG or plasma exchange within 4 weeks prior to the Baseline visit.\n- Ongoing treatment with rituximab/ocreluzimab or calcineurin inhibitors, e.g., tacrolimus, cyclosporine or cyclophosphamide or Neonatal Fc receptor antagonists, e.g. efgartigimod.\n- The patient has started treatment with a complement 5a (C5a) inhibitor, such as eculizumab, within 8 weeks prior to the Baseline visit.\n- Prior treatment with BCMA-directed therapy (e.g. monoclonal antibody, T-cell engager, or CAR-T)."}

Primary endpoints

• {"endpoint_text":"- Proportion of participants who have a decrease of ≥3 points in MG-ADL score at Month 4 compared to Baseline in the active versus placebo group.","definition_or_measurement_approach":"Responder defined as decrease of ≥3 points in MG-ADL total score at Month 4 compared to Baseline; comparison between Descartes-08 and placebo groups."}

Secondary endpoints

• {"endpoint_text":"- Proportion of participants who have a decrease of ≥4 points in MGC score at Month 4 compared to Baseline in the active versus placebo group.","definition_or_measurement_approach":"Responder defined as decrease of ≥4 points in MGC score at Month 4 compared to Baseline; comparison between active and placebo."}
• {"endpoint_text":"- Decrease from Baseline at Month 4 in MG-ADL score in active versus placebo groups.","definition_or_measurement_approach":"Mean change from Baseline in MG-ADL score at Month 4 comparing active versus placebo."}
• {"endpoint_text":"- Decrease from Baseline at Month 4 in MGC score in active versus placebo groups.","definition_or_measurement_approach":"Mean change from Baseline in MGC score at Month 4 comparing active versus placebo."}
• {"endpoint_text":"- Proportion of participants who have a decrease of ≥4 points in QMG score at Month 4 compared to Baseline in the active versus placebo group.","definition_or_measurement_approach":"Responder defined as decrease of ≥4 points in QMG score at Month 4 compared to Baseline; comparison between active and placebo."}
• {"endpoint_text":"- Decrease from baseline in MG-ADL score at Month 2 and Month 3 follow-up in the active versus placebo group.","definition_or_measurement_approach":"Mean change from Baseline in MG-ADL at Months 2 and 3 comparing active versus placebo."}
• {"endpoint_text":"- Decrease from baseline in MGC score at Month 2 and Month 3 follow-up in the active versus placebo group.","definition_or_measurement_approach":"Mean change from Baseline in MGC at Months 2 and 3 comparing active versus placebo."}
• {"endpoint_text":"- Decrease from Baseline at Month 2, Month 3 and Month 4 in QMG score in active versus placebo groups.","definition_or_measurement_approach":"Mean change from Baseline in QMG at Months 2, 3 and 4 comparing active versus placebo."}

Methods

• Site-based recruitment using country-specific materials (posters, brochures, disease fact sheets, site staff training materials) provided for Italy, Poland and Spain (documents: K2_ITA, K2_POL, K2_ESP etc.).
• Recruitment procedure descriptions provided (K1 documents) in English and local languages to guide site staff.
• Study team dialogue aids and posters for clinics to inform patients at participating neurology sites.

Italy

Earliest CTIS Part Ii Submission Date

16-06-2025

Latest Decision Or Authorization Date

07-05-2026

Processing Time Days

325

Number Of Sites

2

Number Of Participants

11

Poland

Earliest CTIS Part Ii Submission Date

10-07-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

302

Number Of Sites

4

Number Of Participants

9

Spain

Earliest CTIS Part Ii Submission Date

08-07-2025

Latest Decision Or Authorization Date

08-05-2026

Processing Time Days

304

Number Of Sites

3

Number Of Participants

9

Primary sponsor

Full Name

Cartesian Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Parexel International (IRL) Limited

Responsibilities

Sponsor duties codes: 1|10|11|12|13|14|2|5|6|7|8 (as listed in CTIS third-party duties)

Name

Eresearchtechnology Inc.

Responsibilities

Rater training

Third parties

• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Rater training","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient reimbursement and travel services","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"1|10|11|12|13|14|2|5|6|7|8","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Study portal, Study training, Visit Essentials, Pre-Screen Navigator","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"4","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Longboat Clinical Limited","duties_or_roles":"Study portal, Study training, Visit Essentials, Pre-Screen Navigator","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Vitalograph Limited","duties_or_roles":"Provision of equipment and equipment training","organisation_type":"Pharmaceutical company"}