A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases
NCT ID: NCT07049081
Last Updated: 2025-12-04
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
PHASE1
42 participants
INTERVENTIONAL
2025-07-17
2030-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Chimeric antigen receptor T cells (LUCAR-G79)
Each subject will be given a single-dose LUCAR-G79 cells infusion at each dose level.
LUCAR-G79 T cells
Prior to infusion of the LUCAR-G79 T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Interventions
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LUCAR-G79 T cells
Prior to infusion of the LUCAR-G79 T 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. Adequate organ function meet screening criteria.
4. Positive test for cluster of differentiation antigen 19 (CD19).
SLE:
* Have been diagnosed of SLE at least 6 months before screening.
* At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
* Fulfill relapsed/refractory SLE conditions.
SSc:
* Have been diagnosed of SSc before screening.
* At screening, mRSS is higher than 10.
* Fulfill relapsed/refractory SSc conditions.
AAV:
* Have been diagnosed of AAV before screening.
* Antineutrophil Cytoplasmic Antibody (ANCA)-related antibodies meet one of the following conditions: a. Positive for anti-myeloperoxidase (MPO) and/or p-ANCA; b. Positive for anti-proteinase 3 (PR3) and/or c-ANCA.
* Fulfill relapsed/refractory AAV conditions.
IIM:
* Have been diagnosed of IIM before screening.
* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
* Fulfill relapsed/refractory IIM conditions.
TAK:
* Have been diagnosed of TAK before screening.
* Active TAK patients meet screening criteria.
* Fulfill relapsed/refractory TAK conditions.
IgG4-RD:
* Have been diagnosed of IgG4-RD before screening.
* Active IgG4-RD patients meet screening criteria.
* Fulfill relapsed/refractory IgG4-RD 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.
18 Years
70 Years
ALL
No
Sponsors
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Nanjing Legend Biotech Co.
INDUSTRY
Responsible Party
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Locations
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The Third The People's Hospital of Bengbu
Bengbu, Anhui, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Shanghai Zhongshan Hospital
Shanghai, Shanghai Municipality, China
The second Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
Countries
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Facility Contacts
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Other Identifiers
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LB2404-0001
Identifier Type: -
Identifier Source: org_study_id
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