CAR-T Cell Therapy Clinical Trial for Relapsed/Refractory Autoimmune Diseases (LUCAR-G79 Study)

This groundbreaking clinical trial explores the safety and effectiveness of LUCAR-G79, an innovative CAR-T cell therapy, for patients with various relapsed or refractory autoimmune diseases. The study focuses on six specific conditions: systemic lupus erythematosus (SLE), systemic sclerosis (SSc), ANCA-associated vasculitis (AAV), idiopathic inflammatory myopathy (IIM), Takayasu arteritis (TAK), and IgG4-related disease (IgG4-RD).

CAR-T cell therapy represents a revolutionary approach that genetically modifies a patient's own immune cells to target disease-causing elements. In this open-label, single-arm study, approximately 42 adult participants will receive a single infusion of LUCAR-G79 after completing lymphodepleting chemotherapy. The treatment process involves four key stages: screening, pre-treatment preparation, the actual CAR-T cell infusion, and extensive follow-up monitoring for two years.

For patients with SLE, eligibility requires positive antibody tests and confirmed diagnosis for at least six months. SSc candidates must have significant skin thickening (mRSS > 10). AAV participants need positive ANCA antibody results, while IIM patients require specific myositis antibodies. Those with TAK or IgG4-RD must show active disease meeting defined criteria.

The research team will primarily evaluate:

• Safety measures including adverse events and dose-limiting toxicities
• How the treatment behaves in the body (pharmacokinetics)
• Determination of optimal dosing

Secondary outcomes focus on disease-specific improvements over 52 weeks:

• SLE: SLEDAI-2K score changes
• SSc: Skin score (mRSS) improvements
• AAV: BVAS activity reduction
• IIM: Muscle strength (MMT-8) enhancement
• TAK: ITAS.A score changes
• IgG4-RD: Response Index improvements

This research holds tremendous promise for autoimmune disease patients who haven't responded to conventional treatments. Autoimmune conditions affect millions worldwide, often causing debilitating symptoms and organ damage when standard therapies fail. CAR-T cell therapy could potentially offer long-term remission by resetting the malfunctioning immune system. The study's comprehensive two-year follow-up will provide crucial data on both immediate effects and lasting benefits.

Participants should be aware that exclusion criteria include active infections, other autoimmune conditions, serious comorbidities like cancer or uncontrolled diabetes, pregnancy, and prior organ transplants. The study recognizes that while experimental therapies carry uncertainties, they may offer hope for patients with limited treatment options. Caregivers should note the intensive monitoring requirements but also the potential for significant quality-of-life improvements if the therapy proves effective.

As autoimmune diseases increasingly challenge global healthcare systems, innovative approaches like CAR-T cell therapy could transform treatment paradigms. This trial represents an important step in evaluating whether immune cell engineering can safely and effectively address various refractory autoimmune conditions that currently lack satisfactory solutions.