A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis

Summary

This Phase IIa, open-label, single-arm study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single infusion of ICG318 in participants with refractory SLE, with or without LN. Participants will receive protocol-specified lymphodepletion followed by ICG318 at the recommended Phase 2 dose.

Eligibility

Key Inclusion Criteria:

1. Age 16-70 years at the time of signing the informed consent
2. Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months.
3. Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody
4. Inadequate response to 2 prior standard of care therapies, used for at least three months
5. SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening
6. For LN cohort participants. Kidney biopsy result within 6 months prior to Screening indicating Class III or IV (alone or in combination with Class V).

Key Exclusion Criteria:

1. Any acute, severe lupus related flare that needs immediate treatment
2. History of antiphospholipid syndrome with thromboembolic event within 12 months
3. History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study.
4. Has drug-induced SLE.
5. History of prior CAR-T therapy.
6. History of bone marrow/hematopoietic stem cell or solid organ transplant or planned receipt during the study period.
7. Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection
8. Receipt of a live/live-attenuated vaccine other than BCG within 8 weeks
9. History within the past year or current clinically significant central nervous system disease, including but not limited to cerebrovascular accident, seizures, severe brain injury, dementia, Parkinson's disease, cerebellar disease, or multiple sclerosis
10. Impaired cardiac function or clinically significant cardiac disease
11. End stage renal disease or severe liver disease
12. Breastfeeding/lactating or pregnant women or women who intend to become pregnant at any time during the study.

Conditions3

Locations4 sites

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