A CAR-T therapy for hard-to-treat systemic lupus with or without lupus nephritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, single-arm Phase 2a trial starts with a safety run-in and then expands to assess safety, tolerability, cellular kinetics, pharmacodynamics, and preliminary clinical activity of a single ICG318 CAR-T cell infusion after lymphodepletion in participants with refractory SLE, with or without LN. ICG318 is a dual-target CAR-T therapy aimed at CD19+ B cells and BCMA+ plasma cells. The study will use a dose determined as the recommended Phase 2 dose to evaluate whether this cellular therapy can achieve clinical improvement in a difficult-to-treat autoimmune population. Eligible participants have persistent disease despite at least two standard therapies, with SLEDAI-2K score ≥7, and LN patients require recent biopsy-confirmed nephritis. Key exclusion criteria include severe active lupus flare, recent thromboembolic events with antiphospholipid syndrome, or prior CAR-T therapy.

Why it matters

Who can join: the full rules

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.

Where it's running

• NorthWell
  New Hyde Park, New York, United States Recruiting
• University of Chicago
  Chicago, Illinois, United States Not yet recruiting
• New York Medical College
  Hawthorne, New York, United States Not yet recruiting
• Fox Chase Cancer Center- Temple BMT
  Philadelphia, Pennsylvania, United States Not yet recruiting

Study contacts

• Study coordinator: Adam Chowdhury, MD, MBA
• Email: Adam.Chowdhury@icellgene.com
• Phone: 2404238999

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.