Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Could a single infusion of modified immune cells tame lupus?

NCT ID NCT06121297

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 27, 2026 · Updated 4 times

Summary

This early-stage trial is testing a treatment called CABA-201 for people with active systemic lupus erythematosus (SLE), including those with lupus nephritis. CABA-201 is made from a patient's own immune cells, which are modified to target and temporarily remove B cells—a key driver of lupus. The study will enroll 28 adults aged 18 to 65 to check safety and see if this approach can calm the disease.

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 type of CAR-T cell therapy made from the patient's own immune cells)
What this could lead to
If it works, this could offer a new way to control lupus by temporarily resetting the immune system, potentially reducing the need for lifelong medications.
What could go wrong
This is an early-phase trial with only 28 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and infections.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 28 people

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

Started

Feb 2024

Expected to finish

Dec 2029

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 65 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.

Inclusion Criteria: * Age ≥18 and ≤65 * A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE. * Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening. * For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria * For non-renal SLE subjects only: Active, moderate to severe SLE 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 * For LN subjects only: The presence of kidney disease other than active lupus nephritis * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Lupus nephritis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

autoimmune disease lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis Systemic lupus erythematosus

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

    20 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 Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brigham and Women's Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

  • Children's Hospital of Philadelphia

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Clinica Universitaria de Navarra

    RECRUITING

    Pamplona, Navarre, 31008, Spain

  • Columbia University Irving Medical Center

    WITHDRAWN

    New York, New York, 10032, United States

  • Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Maisonneuve-Rosemont Hospital

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

    Contact Email: •••••@•••••

  • Northwestern Memorial Hospital

    RECRUITING

    Chicago, Illinois, 60611, United States

  • The University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • Tufts Medical Center

    RECRUITING

    Boston, Massachusetts, 02111, United States

  • UC Davis Health

    RECRUITING

    Sacramento, California, 95817, United States

  • UMass Memorial Hospital

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • UNC Chapel Hill

    RECRUITING

    Chapel Hill, North Carolina, 27599, United States

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Florida Health

    ACTIVE_NOT_RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

  • University of Minnesota

    RECRUITING

    Minneapolis, Minnesota, 55414, United States

  • University of Rochester

    RECRUITING

    Rochester, New York, 14642, United States

  • University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • Yale University

    TERMINATED

    New Haven, Connecticut, 06520, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.