Clinical trial NCT06653556: A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Systemic Lupus Erythematosus (SLE)
Keywords: Refractory pulmonary Hypertension (PAH)
Recurrent/refractory autoimmune hemolytic anemia (r/r AIHA)
Recurrent/refractory lupus nephritis (r/r LN)
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
Collaborators: name: Nanjing Legend Biotech Co.
name: Beijing GoBroad Hospital
First posted: 2024-10-22
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, single-arm, open-label exploratory clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LCAR-AIO, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory systemic lupus erythematosus. Patients who meet the eligibility criteria will receive LCAR-AIO infusion. The study will include the following sequential stages: screening, apheresis, pre-treatment (cell product preparation: lymphodepleting chemotherapy), treatment (LCAR AIO infusion) and follow-up.

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

Primary outcomes:
measure: Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: Incidence of dose-limiting toxicity (DLT)
timeFrame: 30 days after LCAR-AIO infusion (Day 1)
measure: Pharmacokinetics in peripheral blood
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: Recommended Phase 2 Dose (RP2D) regimen finding
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Secondary outcomes:
measure: Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: Change in Physician global assessment (PGA) scores from baseline up to 104 weeks
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: 24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks
timeFrame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
measure: Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)
timeFrame: Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Wuhan Union Hospital
state: Hubei
Study officials:
References: