A Study of LCAR-AIO in Subjects With Relapsed/Refractory Autoimmune Diseases

NCT ID: NCT06866080

Last Updated: 2025-07-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-17
• Study Completion Date: 2025-06-17

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 autoimmune diseases.

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 autoimmune diseases. 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

Relapsed/Refractory Autoimmune Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

LCAR-AIO T cells

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects voluntarily participate in clinical research.

2. Age 18-65 years.

3. Adequate organ function at screening.

4. Clinical laboratory values meet criteria at screening.

SLE:

• Have been diagnosed of SLE at least 6 months before screening.
• At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
• Fulfill relapsed/refractory SLE conditions.

AAV:

• Have been diagnosed of AAV before screening.
• Positive test for anti-PR3 or anti-MPO antibodies at screening.
• Fulfill relapsed/refractory AAV conditions.

SSc:

• Have been diagnosed of SSc before screening.
• At screening, mRSS is higher than 10.
• Fulfill relapsed/refractory SSc conditions.

IIM:

• Have been diagnosed of IIM before screening.
• Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
• Fulfill relapsed/refractory IIM conditions.

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 4 weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing Legend Biotech Co.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of USTC (anhui provincial hospital)

Hefei, , China

Jiangsu Province Hospital

Nanjing, , China

The 1st Affiliated Hospital of WHU

Wenzhou, , China

The Affiliated Hospital of XUZHOU Medical University

Xuzhou, , China

Countries

China

Other Identifiers

LB2305-0002

Identifier Type: -

Identifier Source: org_study_id