NCT06653556 A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
| NCT ID | NCT06653556 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Systemic Lupus Erythematosus (SLE) |
| Study Type | INTERVENTIONAL |
| Enrollment | 34 participants |
| Start Date | 2025-01-08 |
| Primary Completion | 2027-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 34 participants in total. It began in 2025-01-08 with a primary completion date of 2027-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
1. Subjects voluntarily participate in clinical research. 2. Age 18-65 years. 3. Have been diagnosed of SLE at least 6 months before screening. 4. At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Sm antibody should be positive. 5. Fulfill relapsed/refractory SLE conditions. 6. Adequate organ function at screening. 7. Clinical laboratory values meet criteria at screening. Exclusion Criteria: 1. Active infections such as hepatitis and tuberculosis. 2. Other autoimmune diseases. 3. Serious underlying diseases such as tumor, uncontrolled diabetes. 4. 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. 5. Participated in other clinical trials within
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06653556 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus (SLE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06653556 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06653556 currently recruiting?
Yes, NCT06653556 is actively recruiting participants. Contact the research team at qiubaili@hust.edu.cn for enrollment information.
Where is the NCT06653556 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06653556 clinical trial?
NCT06653556 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 34 participants.
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