LUCAR-G79D for adults with relapsed or refractory lupus or inflammatory muscle disease

An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

This trial will test an experimental CAR‑T cell treatment called LUCAR‑G79D in adults whose lupus or inflammatory muscle disease has returned or not responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Nanjing Legend Biotech Co. (Industry-sponsored)
• Drugs / interventions: chimeric antigen receptor, chemotherapy
• Locations: 5 sites (Bengbu, Anhui and 4 other locations)
• Trial ID: NCT07331272 on ClinicalTrials.gov

What this trial studies

This is a prospective, single‑arm, open‑label, dose‑escalation Phase 1 trial of LUCAR‑G79D, a CD19‑targeted CAR‑T cell therapy, in adults with relapsed or refractory systemic lupus erythematosus (SLE) or idiopathic inflammatory myopathies (IIM). Eligible patients undergo screening, receive lymphodepleting chemotherapy, then a single infusion of LUCAR‑G79D, followed by scheduled safety and efficacy follow‑up and pharmacokinetic monitoring. The study will track safety, tolerability, pharmacokinetics, and signals of clinical benefit in this heavily pretreated population. Key eligibility includes age 18–70, adequate organ function, and CD19 positivity, while excluding active infections, other autoimmune diseases, pregnancy, and prior major organ transplantation.

Who should consider this trial

Good fit: Adults aged 18–70 with relapsed or refractory SLE or IIM who are CD19‑positive, have adequate organ function, and can tolerate lymphodepleting chemotherapy are the intended candidates.

Not a fit: Patients with active infections, other uncontrolled autoimmune diseases, serious uncontrolled comorbidities, pregnancy or breastfeeding, prior major organ transplantation, or lacking CD19 expression are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, LUCAR‑G79D could produce meaningful disease control or durable remission in patients who have not responded to standard therapies.

How similar studies have performed: Early case reports and small clinical series of CD19‑targeted CAR‑T therapies in refractory autoimmune diseases have shown promising remissions in some patients, but larger controlled data 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.

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.

Where this trial is running

Bengbu, Anhui and 4 other locations

• The Third The People's Hospital of Bengbu — Bengbu, Anhui, China (Recruiting)
• Nanfang Hospital — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• The Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Recruiting)
• The First Affiliated Hospital of Nanchang University — Nanchang, Jiangxi, China (Not_yet_recruiting)

Conditions Systemic Lupus Erythematosus; Idiopathic Inflammatory Myopathies