ClinicalTrials.gov record NCT06653556

A Study of LCAR-AIO in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

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)

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhaseEarly phase 1A very early study, usually in a small number of people, to learn how the body handles a treatment. It is not designed to show whether the treatment works.
Age18 years old to 65 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a prospective, single-arm, open-label early-phase study testing LCAR-AIO CAR-T cells in adults with relapsed or refractory systemic lupus erythematosus. Participants go through screening, apheresis, pre-treatment including cell product preparation and lymphodepleting chemotherapy, a single LCAR-AIO infusion, and follow-up. Safety, dosing, and disease activity will be followed for at least 104 weeks.

What it is studying. The study evaluates the safety and tolerability of LCAR-AIO CAR-T cells, measures pharmacokinetics and pharmacodynamics, explores signs of clinical effect in SLE, and seeks a recommended Phase 2 dose.

What the researchers hope to learn. To describe treatment-emergent adverse events and dose-limiting toxicities; to characterize pharmacokinetics and pharmacodynamics of LCAR-AIO; to determine a recommended Phase 2 dose; and to collect data on lupus disease activity measures and immunologic markers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Biological
  • LCAR-AIO T cells

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants first complete screening and then undergo apheresis (collection of their immune cells). They receive lymphodepleting (conditioning) chemotherapy, followed by a single infusion of LCAR‑AIO CAR‑T cells. After infusion there is long-term follow-up with blood and urine tests, measurement of CAR‑T levels and immune markers, and SLE activity assessments (including SLEDAI‑2K and physician global assessment) for at least 104 weeks, with ongoing safety monitoring.

How the study is structured. An interventional, single-group, open-label early Phase 1 study. Each participant will have cell collection (apheresis), pre-treatment including cell product preparation and lymphodepleting chemotherapy, a single infusion of LCAR-AIO, and regular follow-up visits with safety monitoring, blood tests for CAR-T levels, and assessments of lupus activity up to at least 104 weeks.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The registry lists this study under Systemic Lupus Erythematosus (SLE). Does it apply to my diagnosis?
  • This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Jan 8, 2025
Primary completion
Sep 30, 2027 (estimated)
Study completion
Sep 30, 2029 (estimated)
Target enrollment
34 participants (estimated)
Last updated on registry
Jan 10, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Principal investigator
Qiubai Li, Professor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborators
  • Nanjing Legend Biotech Co.
  • Beijing GoBroad Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

  • Wuhan Union HospitalRecruiting

    Wuhan, Hubei · China

Terms used on this page · explanations by MedicalUpdates.ai

single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
relapsed/refractory
A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
before screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
pharmacokinetics
How the body absorbs, distributes, breaks down and removes a drug. It is studied by measuring drug levels or related substances at set times after a dose.
chimeric antigen receptor
A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
eligibility criteria
The rules the study team uses to decide who may take part. They are usually split into inclusion criteria and exclusion criteria.
follow-up
The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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