A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
An Open-label Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases (r/r AID)
Nanjing Legend Biotech Co.
36 participants
Oct 14, 2025
INTERVENTIONAL
Conditions
Summary
This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-DKS1 in adult subjects with relapsed/refractory autoimmune diseases.
Eligibility
Inclusion Criteria23
- Subjects voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Clinical laboratory values meet screening criteria.
- 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 Criteria6
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Female subjects who were pregnant, breastfeeding.
- Those with a history of major organ transplantation.
- Have received autologous cell therapy of any target before.
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Interventions
Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07095075