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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
ClinicalTrials.gov ID: NCT07331272
What this study is testing
What is LUCAR-G79D T cells?
LUCAR-G79D T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus (sle).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Adequate organ function meet screening criteria.
- Positive test for cluster of differentiation antigen 19 (CD19). SLE:
- Have been diagnosed of SLE at least 6 months before screening.
You likely can't join if
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Female people who were pregnant, breastfeeding.
- Those with a history of major organ transplantation.
See the full eligibility criteria
- people voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Adequate organ function meet screening criteria.
- 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. 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.
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Female people who were pregnant, breastfeeding.
- Those with a history of major organ transplantation.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Guangzhou, Guangdong, China
- Changsha, Hunan, China
- Xuzhou, Jiangsu, China
- Nanchang, Jiangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Guangzhou, Guangdong, China; Changsha, Hunan, China; Xuzhou, Jiangsu, China; Nanchang, Jiangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.