A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases

Launched by NANJING LEGEND BIOTECH CO. · Jul 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LUCAR-DKS1 for adults who have certain autoimmune diseases that have not improved with previous treatments or have come back after treatment. Autoimmune diseases happen when the body’s immune system mistakenly attacks healthy cells. This study is an early-phase trial, which means it is mainly focused on testing the safety and appropriate dose of the treatment.

Adults between 18 and 70 years old with specific autoimmune diseases—such as lupus (SLE), vasculitis (AAV), scleroderma (SSc), inflammatory myopathies (IIM), or Sjögren’s syndrome (SjS)—may be eligible if they have certain antibodies in their blood and their disease has not responded well to past treatments. Participants will be carefully screened to make sure they meet the study requirements and do not have infections, other serious health problems, or certain conditions like pregnancy. Those who join will receive LUCAR-DKS1 and be closely monitored to see how well the treatment works and if there are any side effects. The study is not yet recruiting participants but aims to help find new options for people with hard-to-treat autoimmune diseases.

Gender

ALL

Eligibility criteria

• * Inclusion Criteria:
• • 1. Subjects voluntary agreement to provide written informed consent.
• • 2. Aged 18 to 70 years, either sex.
• • 3. Clinical laboratory values meet screening criteria.
• • 4. Positive test for CD19 and/ or BCMA
• SLE:
• • Meets at least 1 classification criteria≥6 months for SLE.
• • At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
• • Fulfill relapsed/refractory SLE conditions.
• AAV:
• • Meets the 2022 ACR/EULAR classification criteria for AAV.
• • Positive test for anti-MPO or p-ANCA or anti-PR3 or anti-MPO antibodies at screening.
• • Fulfill relapsed/refractory AAV conditions.
• SSc:
• • Meets the 2013 ACR/EULAR classification criteria for SSc.
• • At screening, mRSS is higher than 10.
• • Fulfill relapsed/refractory SSc conditions.
• IIM:
• • Meets 2017 EULAR/ACR classification criteria for IIM.
• • Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
• • Fulfill relapsed/refractory IIM conditions. SjS：
• • Meets the 2016 ACR/EULAR diagnostic criteria for SjS.
• • Positive test for anti-SSA and/or anti-SSB antibodies at screening.
• • Fulfill relapsed/refractory SjS 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.
• • 6. Have received autologous cell therapy of any target before.