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New treatment option for Systemic Lupus Erythematosus (SLE)
Official title A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
ClinicalTrials.gov ID: NCT06653556
What this study is testing
What is LCAR-AIO T cells?
LCAR-AIO 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, dose-exploration and expansion clinical study of LCAR-AIO in adult subjects with relapsed/refractory systemic lupus erythematosus.
- 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 65
You may be able to join if
- people voluntarily participate in clinical research.
- Age 18-65 years.
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
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, or planning to become pregnant while participating in this study or within 1 year of receiving...
- Participated in other clinical trials within
See the full eligibility criteria
- people voluntarily participate in clinical research.
- Age 18-65 years.
- Have been diagnosed of SLE at least 6 months before screening.
- At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive.
- Fulfill relapsed/refractory SLE conditions.
- Adequate organ function at screening.
- Clinical laboratory values meet criteria at screening.
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Female people who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
- Participated in other clinical trials within
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.