Descartes-08 for Myositis

Recruiting at 1 trial location

Overseen By Vera MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cartesian Therapeutics

Must be taking: Immunosuppressive therapy

Must not be taking: Prohibited immunosuppressants, biologics

Disqualifiers: Interstitial lung disease, severe muscle damage, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called Descartes-08 for individuals with myositis, a muscle condition that can lead to muscle weakness and skin problems, often complicating daily tasks. The trial aims to determine if Descartes-08 can safely and effectively assist those with this condition. Participants should have muscle or skin issues due to dermatomyositis or antisynthetase syndrome and must not have responded well to standard treatments. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Is there any evidence suggesting that Descartes-08 is likely to be safe for humans?

Research has shown that Descartes-08 is generally safe and well-tolerated in people. In earlier studies, patients did not require additional medication to suppress their immune response during treatment, indicating a positive safety sign. Most side effects ranged from mild to moderate, with the most common being IV infusion-related reactions, occurring in about 80% of patients. These reactions are typical for IV-administered treatments and are usually not serious. Notably, there were no reports of severe immune reactions, such as cytokine release syndrome, which can occur with similar treatments. This suggests that Descartes-08 offers a promising safety profile for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myositis?

Unlike traditional treatments for myositis, which often involve corticosteroids and immunosuppressants to reduce inflammation, Descartes-08 offers a unique approach by utilizing a novel mechanism of action. This experimental treatment is designed to target specific pathways in the immune system, potentially leading to more precise and effective management of the disease. Researchers are excited about Descartes-08 because it promises to provide targeted therapy with potentially fewer side effects compared to conventional options, thereby improving the quality of life for patients.

What evidence suggests that Descartes-08 might be an effective treatment for myositis?

Studies have shown promising results for Descartes-08 in treating autoimmune conditions. One study with patients who have systemic lupus erythematosus (SLE) revealed that every participant showed significant improvement by the third month. Descartes-08 targets BCMA, a protein on harmful cells, allowing it to attack these cells without harming most healthy ones. Early research in patients with myasthenia gravis also suggested that Descartes-08 can reduce harmful antibodies. These findings indicate that Descartes-08 could be effective in treating autoantibody-mediated myositis, which is the focus of the current trial. Participants in this trial will receive either Descartes-08 or a placebo to evaluate its effectiveness in treating myositis. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with dermatomyositis or antisynthetase syndrome.

I agree to follow the study rules, use birth control, and get vaccines if needed.

I have dermatomyositis or antisynthetase syndrome affecting my muscles and/or skin.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Descartes-08 or placebo for 24 weeks to evaluate efficacy, safety, and tolerability

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Descartes-08

How Is the Trial Designed?

Group I: Decartes-08 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Cartesian Therapeutics

Lead Sponsor

Trials

10

Recruited

300+

Citations

1.

ir.cartesiantherapeutics.com

ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-announces-strong-efficacy-signal-phase-2

Release Details

100% LLDAS response rate observed in patients with SLE who received Descartes-08 in Phase 2 open-label trial reaching Month 3 follow-up (n=3).

2.

nature.com

nature.com/articles/s41591-025-04171-y

BCMA-directed mRNA CAR T cell therapy for myasthenia ...

The effect size estimate was based on the results of the phase 1b/2a study of Descartes-08 in gMG and historical placebo controls, and it was ...

3.

ir.cartesiantherapeutics.com

ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-highlights-recent-progress-and-outlines

Cartesian Therapeutics Highlights Recent Progress and ...

The primary endpoint will assess the proportion of Descartes-08 participants with an improvement in MG Activities of Daily Living (MG-ADL) score ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07391605

NCT07391605 | Descartes-08 in Autoantibody Myositis

This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells ...

5.

curejm.org

curejm.org/descartes-08-a-new-car-t-trial-for-juvenile-myositis-and-what-parents-should-know/

Descartes‑08: A New CAR‑T Trial for Juvenile Myositis and ...

Focusing on BCMA means Descartes‑08 can attack disease-causing cells without harming most other healthy B cells. Early Adult Studies Give Clues for Kids.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10416207/

Safety and Efficacy of Autologous RNA Chimeric Antigen ...

In this first study of an rCAR-T therapy in an autoimmune disease, Descartes-08 appeared safe and was well-tolerated. Descartes-08 infusions were followed by ...

7.

ir.cartesiantherapeutics.com

ir.cartesiantherapeutics.com/static-files/0c5c6dce-c19c-48cc-a204-70de5ef7b7ba

Updated Data from Phase 2b Trial of Descartes-08 in ...

Safety dataset comprises all subjects who received at least one dose of. Descartes-08 (n=20) or placebo (n=16). All Grade 1–2 adverse events ...