A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases
NCT ID: NCT07095075
Last Updated: 2025-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
36 participants
INTERVENTIONAL
2025-10-14
2029-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Chimeric antigen receptor NK cells (LUCAR-DKS1), single-dose for each subject.
Experimental: chimeric antigen receptor NK cells (LUCAR-DKS1). Dose level1：25 millions /kg Dose level2：50 millions /kg Dose level3：100 millions /kg Dose level4：200 millions /kg Dose level5：400 millions /kg Totally 5 dose groups, each subject will be given a single-dose LUCAR-DKS1 cells infusion at a certain level, subject will be administered at day 1.
LUCAR-DKS1 NK cells
Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Interventions
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LUCAR-DKS1 NK cells
Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
Responsible Party
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Principal Investigators
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Wenfeng Tan Principal Investigator
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Locations
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The Third The People's Hospital of BengBu
Bengbu, Anhui, China
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Hanwei Wang
Role: primary
Zhu Chen
Role: primary
Jian Wu
Role: primary
Li Sun
Role: primary
Songfu Jiang
Role: backup
Other Identifiers
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LB2405-0001
Identifier Type: -
Identifier Source: org_study_id
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