Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Phase
Phase EARLY_PHASE1
Started
2025-01-08
Last updated
2025-01-10
Condition(s) studied
Systemic Lupus Erythematosus (SLE)
Investigational drug(s) / intervention(s)
LCAR-AIO T cells
LCAR-AIO T cells: Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
Study 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
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) — Minimum 104 Weeks after LCAR-AIO infusion (Day 1) An adverse event refers to any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product (investigational or non-investigational), which does not necessarily have a causal relationship with the treatment.
Incidence of dose-limiting toxicity (DLT) — 30 days after LCAR-AIO infusion (Day 1) DLTs are severe adverse events refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
Pharmacokinetics in peripheral blood — Minimum 104 Weeks after LCAR-AIO infusion (Day 1) CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.
Recommended Phase 2 Dose (RP2D) regimen finding — Minimum 104 Weeks after LCAR-AIO infusion (Day 1) RP2D established through dose exploratory.
Trial sites (1)
Facility
City
Region
Status
Wuhan Union Hospital
Wuhan
Hubei
Recruiting
More Union Hospital, Tongji Medical College, Huazhong University of Science and Technology trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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