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

NCT ID: NCT06653556

Last Updated: 2025-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-08

Study Completion Date

2029-09-30

Brief Summary

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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

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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

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Systemic Lupus Erythematosus (SLE)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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LCAR-AIO T Cells

Experimental: Chimeric antigen receptor T cells (LCAR-AIO)

Each subject will be given a single-dose LCAR-AIO cells infusion at each dose level

Group Type EXPERIMENTAL

LCAR-AIO T cells

Intervention Type BIOLOGICAL

Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.

Interventions

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LCAR-AIO T cells

Before treatment with LCAR-AIO T cells, subjects will receive a conditioning regimen.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role collaborator

Beijing GoBroad Hospital

OTHER

Sponsor Role collaborator

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Qiubai Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wuhan Union Hospital

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Qiubai Li, Professor

Role: CONTACT

85726808 ext. 027

Other Identifiers

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LB2305-0001

Identifier Type: -

Identifier Source: org_study_id

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