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RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
16 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety and early effects of one infusion of ICG318 CAR-T, an immune cell treatment. It is for people ages 16–70 with lupus that has not responded well to treatment, with or without kidney disease caused by lupus. Participants first receive treatment to lower certain immune cells, then receive ICG318.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 16–70 years old when signing the consent form.
  • Have had lupus for at least 6 months, diagnosed using the study’s required standards.
  • Have at least one required blood test result: antinuclear antibodies, anti-dsDNA antibodies, or high anti-Smith antibodies. These are immune proteins linked to lupus.
  • Have tried 2 standard treatments for at least 3 months without a good enough response.
  • Have a lupus activity score of 7 or higher on the SLEDAI-2K test at screening.
  • For the lupus kidney disease group: have a kidney tissue test from the 6 months before screening showing Class III or IV disease, with or without Class V.

Who can't join

  • Have a sudden, severe lupus flare needing immediate treatment, lupus caused by a drug, or another condition or treatment that could affect study assessments.
  • Have a history of antiphospholipid syndrome, a condition that can cause blood clots, with a clot event in the past 12 months.
  • Have had CAR-T therapy, or have had or plan to have a bone marrow, blood stem cell, or solid organ transplant during the study.
  • Have a recent serious infection, an ongoing infection, or a risk of serious infection.
  • Have received a live or weakened-live vaccine other than BCG within 8 weeks.
  • Have a significant brain or spinal cord disease now or in the past year, such as stroke, seizures, severe brain injury, dementia, Parkinson’s disease, or multiple sclerosis.
  • Have poor heart function, significant heart disease, end-stage kidney disease, or severe liver disease.
  • Be pregnant, breastfeeding, or planning to become pregnant during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (4)

IL

NY

PA