A Phase 2 interventional study of ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), sponsored by iCell Gene Therapeutics. Recruiting at 4 sites in United States. Open to participants aged 16 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by iCell Gene Therapeutics · Phase 2, Interventional, and Treatment
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.
Systemic Lupus Erythematosus (SLE) is a multisystem, chronic autoimmune disease that may impact multiple organs including the joints, skin, kidney, heart, brain and lungs, with severity ranging from mild to life-threatening. Lupus Nephritis (LN) is the most prevalent and severe form of SLE with high morbidity and mortality and persistent relapses despite current therapies.
SLE, with or without LN is driven largely by pathogenic autoantibodies produced by CD19 expressing B cells and BCMA expressing plasma cells, including long-lived plasma cells.
ICG318, the investigational agent in this clinical trial is an armored, compound chimeric antigen receptor (CAR) composed of two independently functioning CARs that simultaneously target the B-cell CD19 surface antigen and the plasma cell/ long lived plasma cell BCMA surface antigen.
This study is being conducted to evaluate the safety and efficacy of ICG318 in SLE patients with or without LN, who have not shown adequate clinical response to prior therapies.
A single dose of ICG318 following a lymphodepletion regimen will be evaluated.
340 studies on the registry are indexed under Lupus Nephritis; 135 are open to participants now.
This study's planned enrollment of 20 is below the median of 48 across 242 interventional studies indexed under Lupus Nephritis.
Browse Lupus Nephritis studies →iCell Gene Therapeutics is the lead sponsor of 17 studies on the registry; 7 are open to participants now.
Compared within Lupus Nephritis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lupus Erythematosus, Systemic. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biologic drug infusion
Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
Anti-BCMA, Anti-CD19 Compound CAR-T Cells
Number of Adverse Events 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).
Time frame: Starting day 0 and up to 1 year after ICG318 infusion.
DORIS remission rate
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).
Time frame: Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.
Determine the recommended phase 2 dose (RP2D) regimen.
The protocol is based on cohort schema with dose escalation from 0.5x10\^6/kg to 4x10\^6/kg.
Time frame: Starting day 0 and assessed 1 year after ICG318 infusion.
Cmax
Maximum serum concentration of ICG318.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Tmax
Time to maximum serum concentration of ICG318.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
T1/2
Half-life of ICG318 serum concentration.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
AUC
Plasma ICG318 concentration versus time. Total systemic exposure to ICG318 over time.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Rate of B cell elimination and naïve B-Cell recovery
B cell subsets will be assessed by flow cytometry panels and B-Cell receptor sequencing.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Recovery of immunoglobulins
Immunoglobulins IgG, IgM and IgA levels.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
SLE Autoantibody levels
Changes in levels of SLE specific autoantibodies (e.g. dsDNA, Smith etc.)
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Number of patients achieving DORIS remission, LLDAS, Complete or Partial Renal Response (in LN patients)
As per the DORIS and SLEDAI-2K remission criteria.
Time frame: Starting day 0 and assessed at 6 months, and 1 year after ICG318 infusion.
Renal histology
Renal Biopsies will be performed prior to and post-ICG318 infusion.
Time frame: The first biopsy will be obtained prior to ICG318 infusion. Next biopsy will be assessed up to 6 months to 1 year after ICG318 infusion.
Complement levels
Changes in C3 and C4 complement levels in serum.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Serum creatinine levels
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Urine Protein-Creatinine Ratio (uPCR) levels.
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
eGFR value
Time frame: Assessed as per schedule of events up to 1 year after ICG318 infusion.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Dec 2028, 27 months later.
Of 33 phase 2 interventional studies under Lupus Nephritis, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 57. This study's planned 27 months is below that.
How these figures are worked out, and which studies are left out of them.
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iCell Gene Therapeutics