NCT07328581 · iCell Gene Therapeutics
A Phase IIa Study of ICG318 CAR-T in Refractory Systemic Lupus Erythematosus With or Without Lupus Nephritis
What this study is about
This Phase IIa, where both patients and doctors know the treatment given, single-treatment group$1 study includes an initial Safety Run-In followed by dose expansion to evaluate the safety, tolerability, cellular kinetics, how the drug affects the body, and preliminary clinical activity of a single infusion of ICG318 in participants with refractory SLE, with or without LN.
View original scientific 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.
Interventions
BIOLOGICAL
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
Anti-BCMA, Anti-CD19 Compound CAR-T Cells
Primary outcome measures
Number of Adverse Events after ICG318 infusion
Time frame: Starting day 0 and up to 1 year after ICG318 infusion.
Number of participants with Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment Emergent Adverse Events (TEAEs), Adverse Events of Special Interest (AESI), and Dose Limiting Toxicities (DLTs).
DORIS remission rate
Time frame: Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.
DORIS remission defined as no circulating autoantibodies (e.g. dsDNA, Smith etc.) detected, no SLE medications, and SLEDAI-2K score of 0-1 (down from severe 7-10).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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). Key
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
- 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
- Breastfeeding/lactating or pregnant women or women who intend to become pregnant at any time during the study.
Where
- Chicago, Illinois
- Hawthorne, New York
- New Hyde Park, New York
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 17, 2026 · Source of record for eligibility and locations