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Engineered immune cells take on muscle disease

NCT ID NCT06154252

Disease control Sponsor: Cabaletta Bio Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 18, 2026 · Updated 14 times

Summary

This study tests a one-time treatment called CABA-201, made from a patient's own immune cells, for people with active inflammatory muscle diseases like dermatomyositis. The therapy aims to reset the immune system by targeting and removing certain immune cells. Researchers will check if it is safe and if it can improve muscle strength and reduce the need for other medications. About 74 adults and children with active disease despite standard treatments will take part.

What this could mean

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

Active substance
CABA-201 (a CAR-T cell therapy made from the patient's own immune cells, designed to target and destroy certain immune cells)
What this could lead to
If successful, this could offer a new treatment option that reduces muscle inflammation and allows patients to lower or stop their current medications.
What could go wrong
This is an early-phase trial with a small number of participants. CAR-T therapies can cause serious side effects like cytokine release syndrome. It may not work for everyone or may have limited long-term benefits.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 74 people

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

Started

Dec 2023

Expected to finish

Jul 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

6 to 75 years

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.

Adult Cohorts Inclusion Criteria: * Age ≥18 and ≤75 * A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria * Diagnosis of DM, ASyS, or IMNM * Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography * Presence of muscle weakness Other protocol-defined criteria apply. Exclusion Criteria: * Contraindication to leukapheresis * History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * Active infection requiring medical intervention at screening * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections * Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * Significant lung or cardiac impairment * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant Other protocol-defined criteria apply. Juvenile Cohort Inclusion Criteria: * Age ≥6 and ≤17 years at enrollment * A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria * Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography Other protocol-defined criteria apply. Exclusion Criteria: * Contraindication to leukapheresis * History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * Active infection requiring medical intervention at screening * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. * Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * Significant lung or cardiac impairment * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant Other protocol-defined criteria apply.

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Conditions

The condition(s) this trial relates to.

antisynthetase syndrome autoimmune disease dermatomyositis idiopathic inflammatory myopathy immune-mediated necrotizing myopathy juvenile dermatomyositis juvenile idiopathic inflammatory myopathy juvenile polymyositis myositis disease

As listed by the trial registrant

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

Anti-synthetase syndrome Dermatomyositis Idiopathic inflammatory myopathy Immune-mediated necrotizing myopathy Juvenile dermatomyositis Juvenile idiopathic inflammatory myopathy (JIIM) Juvenile myositis Juvenile polymyositis

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

    35 sites in 2 countries. 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

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Accepting Young Adult and Juvenile Patients

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital - Accepting Young Adults and Juvenile Patients

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Healthcare of Atlanta - Accepting Juvenile Patients

    RECRUITING

    Atlanta, Georgia, 30029, United States

  • Children's Hospital Colorado - Accepting Juvenile Patients

    RECRUITING

    Aurora, Colorado, 80046, United States

  • Children's Hospital at Montefiore - Accepting Young Adult and Juvenile Patients

    RECRUITING

    The Bronx, New York, 10467, United States

  • Children's Hospital of Philadelphia - Accepting Young Adult and Juvenile Patients

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Children's Wisconsin Pediatric Rheumatology -Accepting Young Adult and Juvenile Patients

    NOT_YET_RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Duke University Medical Center - Accepting Young Adults and Juvenile Patients

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Emory University - Accepting Adult Patients

    RECRUITING

    Atlanta, Georgia, 30032, United States

  • Hospital for Special Surgery - Accepting Adult and Juvenile Patients

    RECRUITING

    New York, New York, 10021, United States

  • Houston Methodist Hospital - Accepting Adult Patients

    RECRUITING

    Houston, Texas, 77030, United States

  • Johns Hopkins All Children's Hospital - Accepting Juvenile Patients

    RECRUITING

    St. Petersburg, Florida, 33701, United States

  • Kings College Hospital NHS Foundation Trust - Accepting Adult Patients

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Manchester Royal Infirmary - Accepting Adult Patients

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Mayo Clinic - Accepting Adult Patients

    RECRUITING

    Rochester, Minnesota, 55902, United States

  • Mayo Clinic Florida - Accepting Adult Patients

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Memorial Sloan Kettering Cancer Center - Accepting Adult and Juvenile Patients

    RECRUITING

    New York, New York, 10021, United States

  • National Institutes of Health - Accepting Adult and Juvenile Patients

    RECRUITING

    Bethesda, Maryland, 20892, United States

  • Northwestern Memorial Hospital - Accepting Adult Patients

    RECRUITING

    Chicago, Illinois, 60611, United States

  • Oregon Health & Science University - Accepting Adult Patients

    RECRUITING

    Portland, Oregon, 97239, United States

  • Primary Children's Hospital/University of Utah - Accepting Juvenile Patients

    RECRUITING

    Salt Lake City, Utah, 84113, United States

  • Salford Royal Hospital - Accepting Adult Patients

    RECRUITING

    Salford, M6 8HD, United Kingdom

  • Seattle Children's Research Institute - Accepting Juvenile Patients

    RECRUITING

    Seattle, Washington, 98105, United States

  • The University of Chicago Medical Center - Accepting Adult and Juvenile Patients

    RECRUITING

    Chicago, Illinois, 60637, United States

  • UPMC Arthritis and Autoimmunity Center - Accepting Adult Patients

    RECRUITING

    Pittsburgh, Pennsylvania, 15261, United States

  • UPMC Children's Hospital of Pittsburgh - Accepting Juvenile Patients

    RECRUITING

    Pittsburgh, Pennsylvania, 15224, United States

  • University College London Hospitals NHS Foundation Trust - Accepting Adult Patients

    RECRUITING

    London, WC1N 3BG, United Kingdom

  • University of California Irvine - Accepting Adult Patients

    RECRUITING

    Orange, California, 92868, United States

  • University of California, San Francisco Benioff Children's Hospital - Accepting Young Adult and Juvenile Patients

    RECRUITING

    San Francisco, California, 94158, United States

  • University of Kansas Medical Center - Accepting Adult Patients

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Michigan - Accepting Young Adult and Juvenile Patients

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • University of North Carolina at Chapel Hill - Accepting Adult Patients

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas MD Anderson Cancer Center - Accepting Adult Patients

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center - Accepting Juvenile Patients

    RECRUITING

    Dallas, Texas, 75390, United States

    Contact Email: •••••@•••••

  • Vanderbilt University Medical Center - Accepting Adult Patients

    RECRUITING

    Nashville, Tennessee, 37232, United States

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