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 kidney flares?

NCT ID NCT07053800

Disease control Sponsor: Autolus Limited 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Updated 5 times

Summary

This study tests a one-time treatment called Obe-cel, made from a patient's own immune cells, for severe lupus nephritis that hasn't improved with standard care. About 35 people aged 12 to 65 will receive the infusion and be monitored for up to 24 months. The main goal is to see if the treatment can make signs of kidney disease disappear within 6 months.

What this could mean

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

Active substance
Obe-cel (obecabtagene autoleucel), a CAR T-cell therapy
What this could lead to
If it works, this could point toward a new treatment option for people with severe lupus nephritis who haven't responded to other therapies.
What could go wrong
This is an early Phase 2 trial with only 35 participants, so results may not apply to everyone. CAR T-cell therapy can have serious side effects, and long-term safety is unknown.

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 35 people

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

Started

Jan 2026

Expected to finish

Oct 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

12 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: * Willing and able to give written informed consent for participation in the study or written informed consent signed by a legal guardian or representative * Ability and willingness to adhere to protocol's Schedule of Activities and other requirements * Participants must be 12 to 65 years of age inclusive at the time of signing the informed consent. * Female Participants: - a female participant is eligible to participate if she is not pregnant or breastfeeding * Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus. * Positive for at least 1 of the following autoantibodies: antinuclear antibodies (ANA), or anti-dsDNA or anti-Smith. * Severe, Active SLE defined as: * SLEDAI-2K score of ≥ 8 points AND * Severe active LN based on a renal biopsy: Class III, IV or V (V only in combination with class III or IV) * Refractory SLE defined as failure to previous lines of therapy Exclusion Criteria: * Prior treatment at any time with anti-CD19 therapy * More than 1 acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible * Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the participant * History of primary antiphospholipid antibody syndrome * Active or uncontrolled fungal, bacterial, or viral infection * History of malignant neoplasms unless disease free for at least 24 months * History of heart, lung, renal, liver transplant or hematopoietic stem 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.

lupus nephritis systemic lupus erythematosus

As listed by the trial registrant

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

Lupus nephritis

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

    15 sites in 5 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

  • Addenbrooke's Hospital

    RECRUITING

    Cambridge, CB2 0QQ, United Kingdom

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS1 3LH, United Kingdom

    Contact Email: •••••@•••••

  • Great Ormond Street Hospital

    RECRUITING

    London, WC1N 3JH, United Kingdom

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • Instituto D´Or de Pesquisa e Ensino - Hospital São Rafael

    RECRUITING

    Salvador, Estado de Bahia, 41253-190, Brazil

  • Manchester Royal Infirmary

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Queen Elizabeth Hospital Birmingham

    RECRUITING

    Birmingham, B15 2TH, United Kingdom

    Contact Email: •••••@•••••

  • Queen Elizabeth University Hospital

    RECRUITING

    Glasgow, G51 4TF, United Kingdom

  • State University of New York Upstate Medical Center (SUNY)

    RECRUITING

    Syracuse, New York, 13210, United States

  • Texas Transplant Institute

    RECRUITING

    San Antonio, Texas, 78229, United States

  • University College Hospital

    RECRUITING

    London, MW1 2PG, United Kingdom

  • University General Hospital ATTIKON

    RECRUITING

    Athens, 12461, Greece

  • University General Hospital of Patras

    RECRUITING

    Pátrai, 26504, Greece

  • Vinmec Hospital

    RECRUITING

    Hà Nội, 100000, Vietnam

  • Western General Hospital Edinburgh

    RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

More trials for these conditions

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