Actively Recruiting
A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
Led by Nanjing Legend Biotech Co. · Updated on 2025-12-10
36
Participants Needed
5
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary written informed consent provided
- Age 18 to 70 years, any gender
- Clinical laboratory values meet screening criteria
- Positive test for CD19 and/or BCMA
- For SLE: Meets at least 1 classification criteria for 6 months or more; positive for antinuclear antibody, anti-dsDNA antibody, or anti-Smith antibody; relapsed/refractory condition
- For AAV: Meets 2022 ACR/EULAR classification criteria; positive for anti-MPO, p-ANCA, anti-PR3, or anti-MPO antibodies; relapsed/refractory condition
- For SSc: Meets 2013 ACR/EULAR classification criteria; modified Rodnan skin score higher than 10; relapsed/refractory condition
- For IIM: Meets 2017 EULAR/ACR criteria; positive for myositis-associated or specific antibodies; relapsed/refractory condition
- For SjS: Meets 2016 ACR/EULAR diagnostic criteria; positive for anti-SSA and/or anti-SSB antibodies; relapsed/refractory condition
You will not qualify if you...
- Active infections such as hepatitis or tuberculosis
- Presence of other autoimmune diseases
- Serious underlying diseases including tumor or uncontrolled diabetes
- Female subjects who are pregnant or breastfeeding
- History of major organ transplantation
- Prior receipt of any autologous cell therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
The Third The People's Hospital of BengBu
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China, 230036
Actively Recruiting
3
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
4
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
5
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325015
Not Yet Recruiting
Research Team
W
Wenbo Hu
CONTACT
L
Liyuan Yu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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