Overview
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.
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.
Eligibility
Inclusion Criteria:
- Subjects voluntary agreement to provide written informed consent.
- Aged 18 to 70 years, either sex.
- Adequate organ function meet screening criteria.
- Positive test for cluster of differentiation antigen 19 (CD19).
- SLE
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- 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
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- 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:
- Active infections such as hepatitis and tuberculosis.
- Other autoimmune diseases.
- Serious underlying diseases such as tumor, uncontrolled diabetes.
- Female subjects who were pregnant, breastfeeding.
- Those with a history of major organ transplantation.