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Experimental cell therapy takes on lupus and muscle disease

NCT ID NCT07331272

Disease control Sponsor: Nanjing Legend Biotech Co. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new treatment called LUCAR-G79D for people with lupus or inflammatory myopathies that haven't responded to standard therapies. The treatment involves giving patients specially engineered immune cells to help control their disease. The study is small, with 38 adults, and focuses mainly on safety and finding the right dose.

What this could mean

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

Active substance
LUCAR-G79D T cells (a type of immune cell therapy)
What this could lead to
If it works, this could point toward a new treatment option for people with hard-to-control lupus or inflammatory myopathies.
What could go wrong
This is a very early Phase 1 trial with only 38 people, so it may not work or could have serious side effects. The therapy also requires lifelong monitoring and may not lead to a cure.

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 38 people

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

Started

Jan 2026

Expected to finish

Jan 2030

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.

Inclusion Criteria: 1. Subjects voluntary agreement to provide written informed consent. 2. Aged 18 to 70 years, either sex. 3. Adequate organ function meet screening criteria. 4. Positive test for cluster of differentiation antigen 19 (CD19). SLE: * Have been diagnosed of SLE at least 6 months before screening. * At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive. * Fulfill relapsed/refractory SLE conditions. IIM: * Have been diagnosed of IIM before screening. * Positive test for myositis-associated antibodies or myositis-specific antibodies at screening. * Fulfill relapsed/refractory IIM conditions. Exclusion Criteria: 1. Active infections such as hepatitis and tuberculosis. 2. Other autoimmune diseases. 3. Serious underlying diseases such as tumor, uncontrolled diabetes. 4. Female subjects who were pregnant, breastfeeding. 5. Those with a history of major organ transplantation.

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Conditions

The condition(s) this trial relates to.

acquired idiopathic inflammatory myopathy myositis disease systemic lupus erythematosus

As listed by the trial registrant

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

Idiopathic inflammatory myopathies(IIM) Systemic lupus erythematosus (SLE)

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

    5 sites. 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

Locations

  • Nanfang Hospital

    NOT_YET_RECRUITING

    Guangzhou, Guangdong, China

  • The Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

    Contact Email: •••••@•••••

  • The Third The People's Hospital of Bengbu

    RECRUITING

    Bengbu, Anhui, China

  • Xiangya Hospital of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

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