A Study of LUCAR-G79 in Subjects With Relapsed/Refractory Autoimmune Diseases

Legend Biotech

Status and phase: Enrolling; Phase 1

Conditions: Relapsed/Refractory Autoimmune Diseases

Treatments: Biological: LUCAR-G79 T cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT07049081

LB2404-0001

Details and patient eligibility

About

This is a prospective, single-arm, open-label and dose-escalation Investigator Initialed study to evaluate LUCAR-G79 in adult subjects with relapsed/refractory autoimmune diseases.

Full description

This is a prospective, single-arm, open-label clinical study to evaluate the safety, tolerability, pharmacokinetics and efficacy profiles of LUCAR-G79, a chimeric antigen receptor (CAR) -T cell therapy in subjects with relapsed/refractory autoimmune diseases. Patients who meet the eligibility criteria will receive LUCAR-G79 infusion. The study will include the following sequential stages: screening, pre-treatment (lymphodepleting chemotherapy), treatment (LUCAR-G79 infusion) and follow-up.

Enrollment: 42 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.

SSc:

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

AAV:

• Have been diagnosed of AAV before screening.
• Antineutrophil Cytoplasmic Antibody (ANCA)-related antibodies meet one of the following conditions: a. Positive for anti-myeloperoxidase (MPO) and/or p-ANCA; b. Positive for anti-proteinase 3 (PR3) and/or c-ANCA.
• Fulfill relapsed/refractory AAV 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.

TAK:

• Have been diagnosed of TAK before screening.
• Active TAK patients meet screening criteria.
• Fulfill relapsed/refractory TAK conditions.

IgG4-RD:

• Have been diagnosed of IgG4-RD before screening.
• Active IgG4-RD patients meet screening criteria.
• Fulfill relapsed/refractory IgG4-RD 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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42 participants in 1 patient group

Chimeric antigen receptor T cells (LUCAR-G79)

Experimental group

Description:

Each subject will be given a single-dose LUCAR-G79 cells infusion at each dose level.

Treatment:

Biological: LUCAR-G79 T cells