Who may be eligible for the Descartes-08 in Autoantibody Myositis trial?

Inclusion Criteria: * Confirmed diagnosis of one of the following: Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)." * Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement. * Refractory or intolerance to standard therapy. * Stable background immunosuppressive therapy for ≥8 weeks. * Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air). * Informed consent, compliance with visits, contraception, and vaccinations required. Exclusion Criteria: * Isolated interstitial lung disease (ILD) without muscle or skin involvement * Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound). * Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension. * Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's). * Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression. * Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation. * Pregnancy or lactation. * Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods). * Live vaccination within 4 weeks. * History of primary immunodeficiency, organ or bone marrow transplant. * Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.

ClinicalTrials.gov record NCT07391605

Descartes-08 in Autoantibody Myositis

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy, Safety, and Tolerability of Descartes-08 in Patients With Dermatomyositis and Antisynthetase Syndrome

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.

PhasePhase 2A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This randomized, double-blind, placebo-controlled Phase 2 study evaluates Descartes-08—autologous T cells expressing a CAR directed to BCMA—in people with autoantibody-mediated myositis, including dermatomyositis and antisynthetase syndrome. The study compares Descartes-08 with placebo and measures clinical improvement using the 2016 ACR/EULAR Total Improvement Score at 24 weeks.

What it is studying. The study tests whether Descartes-08 (autologous BCMA-directed CAR T cells) compared with placebo produces major clinical improvement at 24 weeks, and it evaluates the safety and tolerability of Descartes-08 in dermatomyositis and antisynthetase syndrome.

What the researchers hope to learn. To evaluate efficacy (proportion achieving ≥60-point improvement on the 2016 ACR/EULAR Total Improvement Score at 24 weeks), and to assess the safety and tolerability of Descartes-08 in patients with dermatomyositis and antisynthetase syndrome.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

This is a randomized, double-blind, placebo-controlled phase 2 study to evaluate the efficacy, safety and tolerability of an autologous T-cells expressing a chimeric antigen receptor (CAR) directed to B-Cell maturation antigen (BCMA) in patients with autoantibody-mediated myositis, including antisynthetase syndrome (ASyS) and dermatomyositis (DM).

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Descartes-08
Other: Placebo

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

Confirmed diagnosis of one of the following:
Dermatomyositis (DM): Probability score ≥55% on the 2017 EULAR/ACR (European Alliance of Associations of Rheumatology/ American College of Rheumatology) criteria for classification of dermatomyositis (corresponding to diagnosis of 'probable or definite' DM). OR Antisynthetase Syndrome (ASyS): Diagnosis based on ACR/EULAR Classification Criteria (1)."
Participants must have dermatomyositis or antisynthetase syndrome with muscle and/or skin involvement.
Refractory or intolerance to standard therapy.
Stable background immunosuppressive therapy for ≥8 weeks.
Adequate hematologic, renal, hepatic, and pulmonary function (SpO₂ ≥92% on room air).
Informed consent, compliance with visits, contraception, and vaccinations required.

Exclusion criteria

Isolated interstitial lung disease (ILD) without muscle or skin involvement
Severe irreversible muscle damage or advanced weakness (e.g., wheelchair-bound).
Interstitial lung disease (ILD) requiring oxygen, severe pulmonary impairment (FVC ≤45%, DLCO ≤40%), or pulmonary hypertension.
Other inflammatory myopathies (PM, IMNM, IBM, cancer- or drug-induced myositis, overlap myositis except Sjögren's).
Other severe neuromuscular, cardiac, pulmonary, or systemic autoimmune diseases requiring immunosuppression.
Significant uncontrolled chronic illnesses or psychiatric conditions interfering with participation.
Pregnancy or lactation.
Recent use of prohibited immunosuppressants/biologics or investigational agents (per washout periods).
Live vaccination within 4 weeks.
History of primary immunodeficiency, organ or bone marrow transplant.
Active or uncontrolled infections: HBV, HCV, HIV, tuberculosis, or recurrent/severe infections.

Study description and what participation involves

The registry record has no detailed description beyond the summary above.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants are randomly assigned, under double-blind conditions, to receive either Descartes-08 (autologous BCMA-directed CAR T cells) or placebo (Plasma-Lyte). Participation involves clinic visits for safety monitoring and disease assessments over the study period (primary outcome measured at 24 weeks), which may include laboratory tests as determined by the study team, and following study rules about medications, vaccinations, and contraception. The study team will monitor for side effects and require adherence to visit and testing schedules.

How the study is structured. A randomized, parallel-group, quadruple-masked (participants, care providers, investigators, and outcomes assessors) placebo-controlled Phase 2 trial. Participants are assigned to receive either Descartes-08 (autologous CAR T cells) or placebo (Plasma-Lyte) and are followed with outcome assessments, including the primary 24-week improvement score.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

Some participants receive a placebo. How is that decided, and what happens for placebo-group participants when the study ends?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on dermatomyositis

This trial is also listed on this site under anti-synthetase syndrome.

Clinical trials59 trials listed for dermatomyositisEvery trial the registry lists for dermatomyositis, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in dermatomyositis researchLatest monthly update: September 2026. Includes: Upadacitinib case reports. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Apr 28, 2026
Primary completion: November 2027 (estimated)
Study completion: May 2028 (estimated)
Target enrollment: 60 participants (estimated)
Last updated on registry: Aug 17, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Cartesian Therapeutics

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Cartesian Therapeutics 📞 617-231-8102 ✉ trials@cartesiantx.com

Participating sites (4)

University of California, IrvineRecruiting
Orange, California, 92868 · United States
Brigham and Women's HospitalRecruiting
Boston, Massachusetts, 02115 · United States
University of North CarolinaRecruiting
Chapel Hill, North Carolina, 27599 · United States
National Neuromuscular Research InstituteRecruiting
Austin, Texas, 78759 · United States

Terms used on this page · explanations by MedicalUpdates.ai

randomized: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
double-blind: Two types of people involved in the study do not know which intervention a participant is receiving. The ClinicalTrials.gov record specifies who is masked, for example participants, care providers, investigators or outcome assessors.
placebo-controlled: A study design in which one group receives a placebo so that the study treatment's effects can be compared with no active treatment.
chimeric antigen receptor: A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
Refractory: A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
standard therapy: Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
immunosuppressive: A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
Informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
FVC: A breathing test that measures the total amount of air a person can blow out after a full breath in. It is often given as a percentage of what is expected for a person's age and size.
DLCO: A breathing test that measures how well the lungs pass oxygen from the air into the blood.
investigational: A treatment that is being tested and has not been approved for this use. It may be approved for a different condition. Being studied does not mean it works or is available outside the study.
washout: A period during which a participant stops a previous treatment before starting the study treatment, so the earlier treatment does not affect the results.
bone marrow transplant: A procedure that replaces blood-forming cells after high-dose treatment. 'Autologous' uses the person's own cells collected beforehand; 'allogeneic' uses cells from a donor.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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