NCT06653556CompletedEarly phase 1
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
An Open-label Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LCAR-AIO for the Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE)
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- First submitted
- 11 Oct 2024
- Start date
- 8 Jan 2025
- Primary completion date
- 6 Jun 2026
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- NCT number
- NCT06653556
What you commit to
- Study type: Interventional · Early phase 1
- Participants enrolled: 3
- From 8 Jan 2025 to the primary completion date, 6 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving LCAR-AIO treatment.
Other illness
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
Other
- Participated in other clinical trials within
Criteria the registry did not label
- Subjects 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wuhan Union Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.