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Gene-Edited cells take on lupus and scleroderma in first human test

NCT ID NCT06925542

Disease control Sponsor: CRISPR Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 28, 2026 · Updated 4 times

Summary

This early-stage trial tests a single infusion of CRISPR-edited immune cells (CTX112) from a healthy donor in 80 adults with severe lupus, scleroderma, or myositis that hasn't responded to standard treatments. The goal is to see if the cells are safe and can reduce disease activity by targeting and calming the overactive immune system. Because it's a Phase 1 study, the main focus is safety, not yet proving the treatment works.

What this could mean

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

Active substance
CRISPR-edited immune cells (CTX112) from a healthy donor
What this could lead to
If it works, this could point toward a one-time treatment that resets the immune system for people with severe autoimmune diseases like lupus.
What could go wrong
This is a very early Phase 1 trial with only 80 people, so safety and effectiveness are not yet proven. There are risks from the cell infusion and possible long-term immune suppression.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 80 people

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

Started

Mar 2025

Expected to finish

Dec 2031

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 to 70 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.

Key Inclusion Criteria: 1. Age ≥18 years and \< 70 years of age. 2. Subjects must voluntarily sign a written informed consent and be willing and able to comply with all study requirements. 3. Adequate hematologic, renal, liver, cardiac and pulmonary organ function. 4. Subjects must agree to use acceptable methods of contraception. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, contraceptive guidelines, and other study procedures. 6. Diagnosis of systemic lupus erythematosus (SLE), systemic sclerosis (SSc) or idiopathic inflammatory myopathy (IIM). For systemic lupus erythematosus (SLE) subjects: \- Diagnosis of SLE by a board-certified rheumatologist that conforms with 2019 ACR/EULAR criteria. For lupus nephritis subjects, active, biopsy-proven proliferative lupus nephritis Class III or IV, either with or without the presence of Class V, and appropriate National Institutes of Health index activity score using the 2018 International Society of Nephrology/Renal Pathology Society criteria. For Systemic Sclerosis (SSc) subjects: \- Diagnosis of diffuse cutaneous systemic sclerosis (dcSSC) or SSc-ILD that conforms with 2013 ACR/EULAR criteria. Subjects should meet active skin or lung disease criteria. For Idiopathic Inflammatory Myopathy (IIM) subjects: \- Diagnosis with dermatomyositis (DM), polymyositis (PM) or myositis as part of rheumatologic overlap syndrome, antisynthetase (ASyS), or immune-mediated necrotizing myopathy (IMNM) that conforms with 2017 ACR/EULAR criteria for inflammatory myopathies. Subjects must meet moderate severe, skin, or lung involvement criteria. Key Exclusion Criteria: 1. Prior anti-CD19 therapy or any gene therapy/genetically modified cell therapy. 2. Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant. 3. Severe active or history of central nervous (CNS) involvement. 4. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease with CNS involvement other than SLE, SSc or IIM. 5. Mixed connective tissue disease with no clear predominant disease. 6. Presence of study disease manifestations or other conditions that are likely to pose increase safety risks and/or confound disease assessments, or pose significant risk to those receiving CAR T cell therapy. 7. History of primary or secondary immunodeficiency. 8. Presence or history of certain bacterial, viral or fungal infection. 9. Malignancy in the last 5 years (with the exception of cancers deemed to be low likelihood for recurrence). 10. Diagnosis of a genetic disorder associated with bone marrow failure or myelodysplastic syndrome. 11. History or current diagnosis of catastrophic anti-phospholipid syndrome or anti phospholipid syndrome that requires ongoing anticoagulation. 12. Pregnant or lactating. 13. Presence or history of disease requiring treatment that is not compatible with the study protocol; presence or history of other conditions that are not compatible with the study protocol.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy antisynthetase syndrome dermatomyositis diffuse cutaneous systemic sclerosis diffuse scleroderma idiopathic inflammatory myopathy immune-mediated necrotizing myopathy juvenile dermatomyositis lupus nephritis myositis disease polymyositis systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Diffuse cutaneous systemic sclerosis Inflammatory myopathy, idiopathic Lupus erythematosus, systemic Lupus nephritis Myositis SLE (systemic lupus) Systemic sclerosis

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

    16 sites in 3 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

  • Boston Medical Center

    RECRUITING

    Boston, Massachusetts, 02118, United States

  • Clinica Universidad de Navarra - Pamplona

    RECRUITING

    Pamplona, 31008, Spain

  • Hospital Universitario Reina Sofia

    RECRUITING

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen del Rocio

    RECRUITING

    Seville, 41013, Spain

  • Medizinische Hochschule Hannover (MHH)

    RECRUITING

    Hanover, 30625, Germany

  • Northwestern Medicine, Robert H. Lurie Comprehensive Cancer Center

    RECRUITING

    Chicago, Illinois, 63110, United States

  • Oregon Health Sciences University

    NOT_YET_RECRUITING

    Portland, Oregon, 97239, United States

  • Stanford University Medical Center

    RECRUITING

    Redwood City, California, 94063, United States

  • Tulane University Medical Center

    RECRUITING

    New Orleans, Louisiana, 70118, United States

  • UC San Diego Health

    NOT_YET_RECRUITING

    La Jolla, California, 92037, United States

  • UCT University Medical Center Mainz

    RECRUITING

    Mainz, 55131, Germany

  • University of Augsburg

    RECRUITING

    Augsburg, 86156, Germany

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of North Carolina TraCS Institute - CTRC

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • Universitätsklinikum Köln

    RECRUITING

    Cologne, 50937, Germany

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63130, United States

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