LUCAR-G79 CAR‑T therapy for relapsed or refractory autoimmune diseases

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)

This study will test LUCAR-G79, a CD19-targeted CAR‑T cell therapy, in adults (18–70) with relapsed or refractory autoimmune diseases who are CD19-positive.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nanjing Legend Biotech Co. (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor, chemotherapy
• Locations: 6 sites (Bengbu, Anhui and 5 other locations)
• Trial ID: NCT07049081 on ClinicalTrials.gov

What this trial studies

This is a prospective, single-arm, open-label, dose-escalation Phase 1 study of LUCAR-G79 administered after lymphodepleting chemotherapy in adults with relapsed or refractory autoimmune diseases. Eligible participants must be CD19-positive and have adequate organ function; treatment consists of leukapheresis, CAR‑T manufacture, lymphodepletion, a single infusion of LUCAR-G79, and scheduled follow-up. The study will collect safety, tolerability, pharmacokinetics, and preliminary efficacy data to define a recommended dose and characterize adverse events. Sites are in China and the sponsor is Nanjing Legend Biotech Co.

Who should consider this trial

Good fit: Adults aged 18–70 with relapsed or refractory autoimmune diseases (such as SLE, systemic sclerosis, ANCA-associated vasculitis, or idiopathic inflammatory myopathies), documented CD19 positivity, and adequate organ function are ideal candidates.

Not a fit: Patients who are CD19-negative, have severe organ dysfunction, are outside the 18–70 age range, or whose disease is unlikely driven by B cells may not receive benefit from this therapy.

Why it matters

Potential benefit: If successful, LUCAR-G79 could produce durable remissions by depleting pathogenic CD19+ B cells and reducing autoimmune activity in patients who have failed other therapies.

How similar studies have performed: Early case reports and small clinical series of CD19-directed CAR‑T therapy in refractory B‑cell–mediated autoimmune diseases have reported dramatic remissions, but larger controlled trials are still limited.

Eligibility criteria

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.

Where this trial is running

Bengbu, Anhui and 5 other locations

• The Third The People's Hospital of Bengbu — Bengbu, Anhui, China (Recruiting)
• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Not_yet_recruiting)
• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• Shanghai Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• The second Affiliated Hospital of Xi'an Jiaotong University — Xi’an, Shanxi, China (Recruiting)

Conditions Relapsed/Refractory Autoimmune Diseases