Systemic Lupus Erythematosus (SLE)Early Phase 1NCT06653556
A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus
A Early Phase 1 study testing LCAR-AIO T cells in people with Systemic Lupus Erythematosus (SLE), run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- LCAR-AIO T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 8 Jan 2025to 6 Jun 2026
- Phase
- Early Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- 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.
- Participated in other clinical trials within
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- LCAR-AIO T cells
- Keywords
- Refractory pulmonary Hypertension (PAH), Recurrent/refractory autoimmune hemolytic anemia (r/r AIHA), Recurrent/refractory lupus nephritis (r/r LN)
- Medical subject headings
- Lupus Erythematosus, Systemic, Hypertension, Pulmonary, Recurrence, Anemia, Hemolytic, Autoimmune, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCAR-AIO T cellsBiological
Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.
| Study group | Role | What they receive |
|---|---|---|
| LCAR-AIO T Cells | Experimental | Experimental: Chimeric antigen receptor T cells (LCAR-AIO)
Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level Receives: Biological: LCAR-AIO T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, severity, and type of treatment-emergent adverse events (TEAEs)
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.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Incidence of dose-limiting toxicity (DLT)
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.
Measured: 30 days after LCAR-AIO infusion (Day 1)
Pharmacokinetics in peripheral blood
CAR positive T cells levels in peripheral blood after LCAR-AIO infusion.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Recommended Phase 2 Dose (RP2D) regimen finding
RP2D established through dose exploratory.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Secondary outcomes (5)
Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 104 weeks
The SELENA-2K scale is a cumulative and weighted index used to assess disease activity across 24 different disease descriptors in patients with lupus. A patient's SELENA-2K total score is the sum of all marked lupus related descriptors (seizure, psychosis, organic brain syndrome, visual disturbance, cranial nerve disorder, lupus headache, cerebrovascular accident, vasculitis, arthritis, myositis, urinary casts, hematuria, proteinuria, pyuria, new rash, alopecia, mucosal ulcers, pleurisy, pericarditis, low complement, increased DNA binding, fever, thrombocytopenia, leukopenia). A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Change in Physician global assessment (PGA) scores from baseline up to 104 weeks
The physician will place a vertical line on a 100-mm visual analog scale on which the left-hand boundary (Score 0) represents "no activity", and the right-hand boundary (score 3) represents "the most severe activity".
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Lupus Low Disease Activity State (LLDAS) response rates at multiple visits post-infusion
Percentage of participants achieving the LLDAS. The LLDAS is a composite measure designed to identify patients achieving a state of low disease activity. The LLDAS response criteria were: (1) SLEDAI-2K <=4, with no activity in major organ systems (Central nervous system, vascular, renal, cardiorespiratory and constitutional); where "no activity" is defined as all items of SLEDAI-2K within these major organ systems equal to 0. (2) no new features of lupus disease activity compared to previous occurred visit, where the "new feature" is defined as any of the SLEDAI-2K 24 items changed from 0 to greater than 0; (3) Physician global assessment (PGA) (score 0-3), <=1; (4) current prednisolone (or equivalent) dose <=7.5 mg dailyultiple visits.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
24h urinary protein/urine protein-to-creatinine ratio (UPCR) changes from baseline up to 104 weeks
Proteinuria will be assessed in lupus nephritis patients basing on 24h urinary protein/UPCR at multiple visits.
Measured: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Changes from baseline in immunological markers and Immunogenicity (anti-drug antibody)
Detection of Immunoglobulins, anti-drug antibodies (anti-dsDNA antibody, anti-Sm antibody, etc.) and anti-drug antibody.
Measured: Time Frame: Minimum 104 Weeks after LCAR-AIO infusion (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start8 Jan 2025
- Primary completion6 Jun 2026
- Study completion6 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Legend Biotech Co., Beijing GoBroad Hospital
- Responsible party
- Principal investigator, Qiubai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06653556
- Sponsor's protocol ID
- LB2305-0001
- Status last verified
- Sep 2026
- First submitted
- 11 Oct 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No