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~5 spots leftby Apr 2026

Descartes-08 for Myasthenia Gravis

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Cartesian Therapeutics

Must be taking: Immunosuppressive drugs

Disqualifiers: Chronic illness, Pregnancy, others

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment called Descartes-08 CAR T-cells in patients with Generalized Myasthenia Gravis. The treatment involves modifying the patient's own immune cells to better attack the cells causing their muscle weakness. The goal is to see if this approach is safe and effective.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, it mentions that immunosuppressive drugs must be deemed necessary by the investigator, which suggests you may continue them if approved by the study team.

What data supports the effectiveness of the treatment Descartes-08 for Myasthenia Gravis?

Research on new treatments for myasthenia gravis (MG) suggests that therapies like chimeric antigen receptor T (CAR-T) cell therapy, which is similar to Descartes-08, may offer faster relief and fewer side effects compared to traditional treatments. These therapies target specific immune processes involved in MG, potentially leading to long-term improvement.¹ ² ³ ⁴ ⁵

Is Descartes-08 (Anti-BCMA CAR-T cell therapy) generally safe for humans?

There is a report of a patient developing a movement disorder similar to Parkinson's disease after receiving a BCMA-targeted CAR-T cell therapy, which suggests that this treatment may have neurological side effects. Close monitoring of patients receiving this therapy is recommended due to these potential risks.⁶ ⁷ ⁸ ⁹ ¹⁰

How is the Descartes-08 treatment different from other treatments for myasthenia gravis?

Descartes-08 is a unique treatment for myasthenia gravis because it uses a type of cell therapy called CAR-T cell therapy, which involves modifying a patient's own immune cells to better target and attack specific cells involved in the disease. This approach is different from traditional treatments that often involve medications to suppress the immune system or manage symptoms.³ ⁴ ¹¹ ¹² ¹³

Research Team

Eligibility Criteria

This trial is for adults over 18 with Generalized Myasthenia Gravis (MG), a condition causing muscle weakness. Participants must be taking immunosuppressive drugs, as deemed necessary by the study's doctor. It's not for those with major unmanaged chronic illnesses or pregnant/lactating individuals.

Inclusion Criteria

People who test negative for certain antibodies are allowed to participate.

I have been diagnosed with Generalized Myasthenia Gravis.

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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

Patient is pregnant or lactating

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Up to three ascending doses of Descartes-08 will be administered to each of 3 to 6 patients, staggered at least 21 days apart with a safety review between each dose

9 weeks

Randomized Control Trial

Patients receive up to 6 doses in three different schedules depending on the arm they were enrolled into and will be monitored for safety and tolerability

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

Descartes-08 (CAR T-cell Therapy)

Trial OverviewThe trial is testing Descartes-08 CAR-T cells to see if they are safe and can help improve symptoms in patients with MG. This Phase IIb study will give participants this new type of cell therapy that's designed to target and modify their immune system.

Participant Groups

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Phase IIa ExpansionExperimental Treatment1 Intervention

Generalized Myasthenia Gravis

Group II: Phase 1b Dose-EscalationExperimental Treatment1 Intervention

Generalized Myasthenia Gravis

Group III: Phase IIb Randomized Control TrialPlacebo Group1 Intervention

Generalized Myasthenia Gravis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Cartesian Therapeutics

Lead Sponsor

Trials

Recruited

300+

Findings from Research

Eculizumab (ECU) treatment in patients with acetylcholine receptor autoantibody positive generalized myasthenia gravis (AChR MG) leads to significant changes in adaptive immunity, including reduced activation markers in memory CD4+ T cells and increased regulatory T cell populations, suggesting a modulation of immune response.

The study, involving 3 patients before and after at least 3 months of stable ECU therapy, indicates that ECU not only inhibits the complement system but also affects lymphocyte populations, enhancing our understanding of its mechanism of action in treating MG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular changes in eculizumab early responders with generalized myasthenia gravis.Li, Y., Yi, JS., Howard, JF., et al.[2021]

In a study of 32 patients with refractory myasthenia gravis, daily administration of 3 mg tacrolimus for one year significantly improved clinical symptoms, as evidenced by reductions in various clinical scores and a decreased need for prednisone.

Tacrolimus treatment was associated with significant changes in soluble costimulatory molecules and IL-2 levels, suggesting these molecules could serve as potential biomarkers for monitoring the disease and treatment response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tacrolimus on soluble costimulatory molecules in patients with refractory myasthenia gravis.Wu, H., Chen, L., Zhou, X., et al.[2023]

In a study of 128 myasthenia gravis patients who underwent thymectomy, 68.8% showed improvement after an average follow-up of about 52 months, indicating that thymectomy can be an effective treatment for many patients.

The presence of thymoma was identified as a significant predictor of a suboptimal clinical outcome post-surgery, suggesting that patients with thymomatous myasthenia gravis may require closer monitoring and additional treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants of Suboptimal Outcome Following Thymectomy in Myasthenia Gravis.Shreedhara, AS., Nair, SS., Unnikrishnan, M., et al.[2022]