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Experimental cell therapy takes on stubborn autoimmune diseases

NCT ID NCT07049081

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 study tested a new cell therapy called LUCAR-G79 in just 3 adults with severe autoimmune diseases that did not respond to standard treatments. The therapy uses specially engineered immune cells to target and potentially calm the overactive immune system. The main goals were to check safety and find the right dose, but the study was stopped early, so we have limited information.

What this could mean

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

Active substance
LUCAR-G79 T cells (a type of immune cell therapy)
What this could lead to
If successful, this could point toward a new treatment option for people with hard-to-treat autoimmune diseases like lupus.
What could go wrong
This was a very early, tiny study (only 3 people) that was terminated, so results are limited. Cell therapies can have serious side effects, and it's unclear if this approach will work for autoimmune conditions.

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

3 people

The number who actually took part.

Started

Jul 2025

Finished

Mar 2026

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. SSc: * Have been diagnosed of SSc before screening. * At screening, mRSS is higher than 10. * Fulfill relapsed/refractory SSc conditions. AAV: * Have been diagnosed of AAV before screening. * Antineutrophil Cytoplasmic Antibody (ANCA)-related antibodies meet one of the following conditions: a. Positive for anti-myeloperoxidase (MPO) and/or p-ANCA; b. Positive for anti-proteinase 3 (PR3) and/or c-ANCA. * Fulfill relapsed/refractory AAV 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. TAK: * Have been diagnosed of TAK before screening. * Active TAK patients meet screening criteria. * Fulfill relapsed/refractory TAK conditions. IgG4-RD: * Have been diagnosed of IgG4-RD before screening. * Active IgG4-RD patients meet screening criteria. * Fulfill relapsed/refractory IgG4-RD 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.

autoimmune disease granulomatosis with polyangiitis idiopathic inflammatory myopathy immunoglobulin G4-related sclerosing disease systemic lupus erythematosus systemic sclerosis Takayasu arteritis

As listed by the trial registrant

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

Relapsed/refractory autoimmune diseases

Contacts and locations

Locations

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou, Jiangsu, China

  • The Third The People's Hospital of Bengbu

    Bengbu, Anhui, China

  • The second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, China

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