Descartes-08 for Lupus

Overseen By Cartesian Clinical Trials

Age: Any Age

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cartesian Therapeutics

Must not be taking: Anticoagulants

Disqualifiers: Chronic illness, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 34

Duration: 6 weeks

50 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 to determine its safety and effectiveness for young people with certain chronic diseases. These include childhood-onset systemic lupus erythematosus (where the immune system attacks the body), ANCA-associated vasculitis (inflammation of blood vessels), juvenile myasthenia gravis (muscle weakness), and juvenile dermatomyositis (muscle inflammation). The trial consists of two parts: one to find a safe dose and another to assess the treatment's effectiveness. Candidates may be suitable if they have one of these conditions with moderate symptoms and a history of needing systemic treatment. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering a chance to be among the first to benefit from this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on anticoagulation therapy, you may be able to continue if your doses have been stable for a certain period. It's best to discuss your specific medications with the trial team.

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

Research has shown that Descartes-08 offers potential benefits for people with systemic lupus erythematosus (SLE). A recent study found that patients who took Descartes-08 experienced positive results, with no reports of the serious side effect known as cytokine release syndrome. This suggests the treatment might be safe for patients. Additionally, Descartes-08 does not require extra medications to suppress the immune system, which can sometimes cause their own side effects.

While these findings are encouraging, safety remains under study, especially in younger people. However, the absence of major side effects so far is promising for those considering joining the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for lupus, which often include corticosteroids, immunosuppressants, and biologics, Descartes-08 is a cell-based therapy. Researchers are excited about Descartes-08 because it involves infusions of specially engineered cells designed to modulate the immune system more precisely. This innovative approach could offer a new way to manage lupus by potentially reducing inflammation and autoimmune activity at its source, promising a more targeted and potentially less toxic treatment option.

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

Research has shown that Descartes-08 yields promising results for treating systemic lupus erythematosus (SLE). In one study, all participants experienced a significant reduction in disease activity, with everyone responding well after three months. This suggests that Descartes-08 might help manage SLE symptoms. The treatment was well-tolerated, with no severe side effects reported. These findings strongly indicate that Descartes-08 could be a potential treatment for lupus and similar conditions. Participants in this trial will receive Descartes-08 infusions, with Part 1 focusing on establishing the maximum tolerated dose and Part 2 administering the treatment once weekly for six weeks. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for children, adolescents, and young adults aged 12 or older with autoimmune disorders like lupus, juvenile myasthenia gravis, dermatomyositis, or vasculitis. They must have moderate disease symptoms and a history of systemic treatment. Consent from the patient or guardian is required.

Inclusion Criteria

I am 12 years old or older.

My symptoms are moderate, not mild or severe.

I have received systemic treatment before.

Exclusion Criteria

Hemoglobin < 8.0 g/dL

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

I do not have hepatitis C or, if I tested positive for it, my viral load is undetectable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Intra-patient dose escalation to establish Maximum Tolerated Dose over six infusions

6 weeks

6 weekly infusions

Treatment

Descartes-08 infusions at the maximum tolerated dose level once weekly

6 weeks

6 weekly infusions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Visits on Days 22, 50 and Months 3, 6, 9, 12

What Are the Treatments Tested in This Trial?

Interventions

• Descartes-08

Trial Overview

The trial tests Descartes-08's safety and effectiveness in managing autoimmune conditions in younger patients. It aims to see how well they tolerate the drug and if it improves their symptoms.

How Is the Trial Designed?

Group I: Part 2: Decartes-08 infusions once weekly for 6 weeks Experimental Treatment 1 Intervention

Descartes-08 infusions at the maximum tolerated dose level from Part 1.

Group II: Part 1: Decartes-08 to establish Maximum tolerated dose Experimental Treatment 1 Intervention

Intra-patient dose escalation arm with three dose levels over the course of six infusions of cell product.

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

Initial data reported significant reduction in disease activity following initial Descartes-08 treatment with 100% of participants who reached ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06038474

Study Details | NCT06038474 | Descartes-08 for Patients ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

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.

clinicaltrialvanguard.com

clinicaltrialvanguard.com/news/cartesians-sle-trial-shows-strong-efficacy-for-descartes-08/

Cartesian's SLE Trial Shows Strong Efficacy for Descartes-08

In an open-label Phase 2 study of systemic lupus erythematosus, Descartes-08 produced a 100% LLDAS response at Month 3 in all evaluable ...

5.

ir.cartesiantherapeutics.com

ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-highlights-progress-and-2025-strategic

Release Details

Consistent with previously reported data, Descartes-08 was observed to be well-tolerated, supporting outpatient administration without the need ...

6.

ir.cartesiantherapeutics.com

ir.cartesiantherapeutics.com/news-releases/news-release-details/cartesian-therapeutics-reports-third-quarter-2025-financial

Cartesian Therapeutics Reports Third Quarter 2025 ...

Preliminary data from Phase 2 trial of Descartes-08 in systemic lupus erythematosus expected by end of year. Initiation of Phase 2 pediatric ...