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Engineered immune cells take on rare muscle disorders

NCT ID NCT07391605

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 18, 2026 · Updated 3 times

Summary

This Phase 2 trial tests a personalized cell therapy called Descartes-08 for people with dermatomyositis or antisynthetase syndrome, two rare autoimmune diseases that cause muscle weakness and inflammation. The therapy uses a patient's own immune cells, modified to target and reduce harmful immune activity. About 60 participants will receive either Descartes-08 or a placebo to see if it leads to major improvement in muscle function and disease control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Descartes-08 (a personalized cell therapy made from the patient's own immune cells, engineered to target and destroy certain immune cells that drive the disease)
What this could lead to
If successful, this could point toward a new treatment option for people with these rare autoimmune muscle diseases, potentially reducing symptoms and improving quality of life.
What could go wrong
This is an early Phase 2 trial with only 60 participants, so results may not apply to everyone. The therapy is complex and carries risks like infusion reactions or infections. It may not work better than placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • National Neuromuscular Research Institute

    RECRUITING

    Austin, Texas, 78759, United States

  • University of California, Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of North Carolina

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

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