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Engineered immune cells take aim at Hard-to-Treat lupus

NCT ID NCT07328581

Disease control Sponsor: iCell Gene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 18, 2026 · Updated 4 times

Summary

This early-phase trial tests a new type of cell therapy called BCMA-CD19-IL-15/IL15sushi compound CAR T cells in 20 people with severe lupus that hasn't improved with standard treatments. The therapy aims to reset the immune system by targeting and eliminating faulty immune cells. Researchers will monitor safety and check if the treatment can reduce lupus disease activity and autoantibodies.

What this could mean

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

Active substance
BCMA-CD19-IL-15/IL15sushi compound CAR T cells (a type of immune cell therapy)
What this could lead to
If successful, this could offer a new treatment option for people with severe lupus that hasn't responded to standard therapies, potentially reducing disease activity and need for medications.
What could go wrong
This is an early-phase trial with only 20 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 2

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

Participants

About 20 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 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

16 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 16-70 years at the time of signing the informed consent 2. Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months. 3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody 4. Inadequate response to 2 prior standard of care therapies, used for at least three months 5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening 6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V). Key Exclusion Criteria: 1. Any acute, severe lupus related flare that needs immediate treatment 2. History of antiphospholipid syndrome with thromboembolic event within 12 months 3. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study. 4. Has drug-induced SLE. 5. History of prior CAR-T therapy. 6. History of bone marrow/hematopoietic stem cell or solid organ transplant or planned receipt during the study period. 7. Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection 8. Receipt of a live/live-attenuated vaccine other than BCG within 8 weeks 9. History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis 10. Impaired cardiac function or clinically significant cardiac disease 11. End stage renal disease or severe liver disease 12. Breastfeeding/lactating or pregnant women or women who intend to become pregnant at any time during the study.

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Conditions

The condition(s) this trial relates to.

autoimmune disease 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 (LN) Systemic lupus erythematosus (SLE)

How to take part

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

  1. The places running it

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

  2. 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 ↗

  3. 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

Locations

  • Fox Chase Cancer Center- Temple BMT

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19111, United States

  • New York Medical College

    NOT_YET_RECRUITING

    Hawthorne, New York, 10532, United States

  • NorthWell

    RECRUITING

    New Hyde Park, New York, 11040, United States

  • University of Chicago

    NOT_YET_RECRUITING

    Chicago, Illinois, 60637, United States

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