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

Legend Biotech

Status and phase: Withdrawn; Early Phase 1

Conditions: Relapsed/Refractory Autoimmune Diseases

Treatments: Biological: LCAR-AIO T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT06866080

LB2305-0002

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Chimeric antigen receptor T cells (LCAR-AIO)

Experimental group

Description:

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

Treatment:

Biological: LCAR-AIO T cells