A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases

Plain-language summary

This study examines the LUCAR-G79 T cell therapy in people with relapsed or refractory autoimmune diseases (such as systemic lupus, systemic sclerosis, and ANCA-associated vasculitis). It is open to people aged 18-70 who test positive for CD19 and have one of the relevant autoimmune diagnoses. The study is being conducted in Phase 1 and is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Recruiting

Sponsor

Nanjing Legend Biotech Co.

Intervention

LUCAR-G79 T cells

Start date

7/17/2025

Estimated completion

4/30/2030

Countries

China

Related genes

Locations

• Bengbu, China
• Nantong, China
• Suzhou, China
• Xuzhou, China
• Shanghai, China
• Xi’an, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.