Not Yet RecruitingPhase 1/2

BCMA-CD19 cCAR T for the Treatment of Refractory Lupus

20 participantsStarted 2026-01

Plain-language summary

This is a Phase I, IIa, Single-Arm, interventional, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19-IL-15/IL15sushi cCAR T cells in patients with relapsed and/or refractory SLE, with or without Lupus Nephritis.

Who can participate

Age range16 Years – 70 Years

SexALL

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Inclusion criteria

✓. 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)6.

Exclusion criteria

✕. Any acute, severe lupus related flare that needs immediate treatment
✕. 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.
✕. Has drug-induced SLE.
✕. History of prior CAR-T therapy.
✕. 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
✕. Receipt of a live/live-attenuated vaccine other than BCG within 8 weeks

What they're measuring

Number of Adverse Events after ICG318 infusion

Timeframe: Starting day 0 and up to 1 year after ICG318 infusion.

DORIS remission rate

Timeframe: Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.

Trial details

NCT IDNCT07328581

SponsoriCell Gene Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

Contact for this trial

Kevin Pinz, MS

6315386218 kevin.pinz@icellgene.com

View on ClinicalTrials.gov More Systemic Lupus Erythematosus (SLE) trials