Tests ICG318 CAR-T cells in people with hard-to-treat lupus, with or without kidney disease
Tests ICG318 CAR-T cells in people with hard-to-treat lupus.
Plain-language title generated from the registry record
Registry title: A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
Key facts
- Where
- Chicago, Hawthorne, New Hyde Park, and Philadelphia, United StatesSee the 4 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 16 and 70 years old?
Source: NCT07328581, who can take part
Where in United States
- University of ChicagoChicago, United StatesNot yet recruiting
- New York Medical CollegeHawthorne, United StatesNot yet recruiting
- NorthWellNew Hyde Park, United StatesTaking people
- Fox Chase Cancer Center- Temple BMTPhiladelphia, United StatesNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- iCell Gene Therapeutics
- Trial code
- NCT07328581
- Record updated
- 17 September 2026
- Original description
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.Read full original descriptionShow less
A Phase IIa, Open-Label, Single-Arm Study With an Initial Safety Run-In and Dose Expansion of ICG318 (BCMA-CD19-IL-15/IL15sushi cCAR T) in Participants With Refractory Systemic Lupus Erythematosus, With or Without Lupus Nephritis
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.
Inclusion: Age 16-70 years at the time of signing the informed consent; Have a diagnosis of SLE by EULAR/ACR 2019 criteria for ≥6 months; Have at least one of an antinuclear antibody, anti-double-stranded deoxyribonucleic acid (dsDNA), or elevated anti-Smith (Sm) antibody; Inadequate response to 2 prior standard of care therapies, used for at least three months; SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥7 at Screening; 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).
Exclusion: Has drug-induced SLE; History of prior CAR-T therapy; Receipt of a live/live-attenuated vaccine other than BCG within 8 weeks; History of antiphospholipid syndrome with thromboembolic event within 12 months; History or current diagnosis of any disease, condition or treatment that may confound clinical assessments in the study; History of bone marrow/hematopoietic stem cell or solid organ transplant or planned receipt during the study period; Recent serious or ongoing infection, or risk for serious infection, or acute or chronic infection; 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; Impaired cardiac function or clinically significant cardiac disease; End stage renal disease or severe liver disease; Any acute, severe lupus related flare that needs immediate treatment; Breastfeeding/lactating or pregnant women or women who intend to become pregnant at any time during the study.