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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The Third The People's Hospital of Bengbu
  Bengbu, Anhui, China Recruiting
• The Affiliated Hospital of Xuzhou Medical University
  Xuzhou, Jiangsu, China Recruiting
• Nanfang Hospital
  Guangzhou, Guangdong, China Not yet recruiting
• Xiangya Hospital of Central South University
  Changsha, Hunan, China Not yet recruiting
• The First Affiliated Hospital of Nanchang University
  Nanchang, Jiangxi, China Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Long-Term Extension of enpatoran for cutaneous lupus symptoms

  This extension study tests whether continuing enpatoran is safe and helpful for people with skin lupus who completed previous trials, for up to about two years.

  Recruiting Phase 3 EMD Serono · Troy, Michigan · NCT07840287

• Targeting B cells and plasma cells in lupus with a dual-action antibody

  A new injectable therapy (F182112) will be tested in adults with systemic lupus erythematosus to see if it can help by hitting both CD3 on immune cells and BCMA on B cells and plasma cells.

  Recruiting Phase 1 Shandong New Time Pharmaceutical Co., LTD · Shanghai · NCT07829614

• FT839 therapy for autoimmune diseases

  This trial tests FT839, given alone or with rituximab, to see if it is safe and can help people with certain autoimmune diseases who have not responded to other treatments.

  Recruiting Phase 1/2 Fate Therapeutics · Fullerton, California · NCT07800871

• Triple therapy with voclosporin, MMF and prednisolone in lupus nephritis

  This trial tests whether adding voclosporin to standard lupus nephritis treatment (MMF and prednisolone) early on improves kidney inflammation compared to standard therapy alone.

  Recruiting Phase 4 Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07760480

• Carotid ultrasound to guide prevention of heart disease in inflammatory rheumatic diseases

  In people with inflammatory rheumatic diseases like RA, PsA, AxSpA, or SLE who are at modest cardiovascular risk, a carotid ultrasound test is used to see if they should start stronger lipid-lowering therapy to prevent heart problems.

  Recruiting at 7 sites Phase 4 Instituto de Investigación Marqués de Valdecilla · Alicante, Alicante and 16 other locations · NCT07611747

• Periodontal Health in Rare Kidney Conditions and Controls

  This study tests how common periodontitis is in people with rare kidney disorders and compares it to CKD patients and people without kidney disease.

  Recruiting Institutul Clinic Fundeni · Bucharest · NCT07575347

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.