A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)

Legend Biotech

Status and phase: Enrolling; Phase 1

Conditions: Idiopathic Inflammatory Myopathies(IIM); Systemic Lupus Erythematosus (SLE)

Treatments: Biological: LUCAR-G79D T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT07331272

LB2404D-0001

Details and patient eligibility

About

This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.

Full description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79D, a chimeric antigen receptor (CAR) -T cell therapy in subjects with r/r SLE and r/r IIM. Patients who meet the eligibility criteria will receive LUCAR-G79D infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79D infusion) and follow-up.

Enrollment: 38 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subjects voluntary agreement to provide written informed consent.
2. Aged 18 to 70 years, either sex.
3. Adequate organ function meet screening criteria.
4. Positive test for cluster of differentiation antigen 19 (CD19).

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.

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.
5. Those with a history of major organ transplantation.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Chimeric antigen receptor T cells (LUCAR-G79D)

Experimental group

Description:

Each subject will be given a single-dose LUCAR-G79D cells infusion at each dose level.

Treatment:

Biological: LUCAR-G79D T cells