Descartes-08 for Myasthenia Gravis

Recruiting at 2 trial locations

Overseen By Dr., MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Cartesian Therapeutics

Must be taking: Immunosuppressive drugs

Must not be taking: Rituximab, Ocrelizumab, Calcineurin inhibitors

Disqualifiers: Chronic illness, Neuromuscular disease, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications if they are deemed necessary by the investigator. However, your medication doses must be stable for at least 8 weeks before starting the trial. Some specific treatments, like certain biologics and immunoglobulins, must be stopped a few weeks before the trial.

What is the purpose of 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.

Eligibility Criteria

Adults with generalized myasthenia gravis who test positive for acetylcholine receptor autoantibodies can join this trial. Specific eligibility details are not provided, but typically participants must meet certain health standards and may be excluded based on factors that could interfere with the study or their safety.

Inclusion Criteria

My myasthenia gravis is moderate to severe.

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

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.

My kidney function is reduced with a creatinine clearance below 30 mL/min.

I have had a transplant or have a primary immune deficiency.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive the investigational mRNA CAR T-cell therapy Descartes-08 or placebo

6 months

Treatment Part 2

Eligible participants continue receiving the investigational therapy or placebo

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 months

Treatment Details

Interventions

• Descartes-08

Trial Overview The AURORA Study is testing Descartes-08, an experimental mRNA CAR T-cell therapy against a placebo to see if it's safe and works for treating myasthenia gravis. The first part of the study lasts about 6 months, followed by an optional second part lasting approximately 8 months.

Participant Groups

Group I: Decartes-08 Experimental Treatment 1 Intervention

This group will undergo leukapheresis and receive manufactured Decartes-08

Group II: Placebo Placebo Group 1 Intervention

This group will receive placebo

Who Is Running the Clinical Trial?

Cartesian Therapeutics

Lead Sponsor

Trials

10

Recruited

300+