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Systemic Lupus Erythematosus (SLE)Phase 2NCT07328581

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

A Phase 2 study testing ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by iCell Gene Therapeutics at 4 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 16 to 70 years
What is being tested?
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
4 sitesUnited States
Study dates
Sep 2026to Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Adam Chowdhury, MD, MBA contact

2404238999

Adam.Chowdhury@icellgene.com

United States4 sites, 4 recruiting

  • University of Chicago

    Chicago, Illinois, 60637

    Melissa Tesher, MD, 615-693-0748, Sydni.Hill@bsd.uchicago.edu

    Not yet recruiting

  • New York Medical College

    Hawthorne, New York, 10532

    Allyson Flowers, MD, 914-614-4270, aflower@nymc.edu

    Not yet recruiting

  • NorthWell

    New Hyde Park, New York, 11040

    Jonathan Fish, MD, 718-470-3460, jfish1@northwell.edu

    Recruiting

  • Fox Chase Cancer Center- Temple BMT

    Philadelphia, Pennsylvania, 19111

    Rashmi Khanal, MD, 215-707-7464, heather.roos@temple.edu

    Not yet recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

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.

Being tested
ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion
Keywords
Lupus, autoimmune disease, CAR-T Cell, Refractory disease, CD19, BCMA, Lupus Nephritis (LN), Systemic Lupus Erythrematosus (SLE)
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletionBiological

    Anti-BCMA, Anti-CD19 Compound CAR-T Cells

Study groups in NCT07328581
Study groupRoleWhat they receive
Single armExperimentalBiologic drug infusion
Receives: Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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).

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

Secondary outcomes (14)

  1. 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.

    Measured: Starting day 0 and assessed 1 year after ICG318 infusion.

  2. Cmax

    Maximum serum concentration of ICG318.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  3. Tmax

    Time to maximum serum concentration of ICG318.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  4. T1/2

    Half-life of ICG318 serum concentration.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  5. AUC

    Plasma ICG318 concentration versus time. Total systemic exposure to ICG318 over time.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  6. 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.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  7. Recovery of immunoglobulins

    Immunoglobulins IgG, IgM and IgA levels.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  8. SLE Autoantibody levels

    Changes in levels of SLE specific autoantibodies (e.g. dsDNA, Smith etc.)

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  9. Number of patients achieving DORIS remission, LLDAS, Complete or Partial Renal Response (in LN patients)

    As per the DORIS and SLEDAI-2K remission criteria.

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

  10. Renal histology

    Renal Biopsies will be performed prior to and post-ICG318 infusion.

    Measured: 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.

  11. Complement levels

    Changes in C3 and C4 complement levels in serum.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  12. Serum creatinine levels

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  13. Urine Protein-Creatinine Ratio (uPCR) levels.

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

  14. eGFR value

    Measured: Assessed as per schedule of events up to 1 year after ICG318 infusion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07328581
Sponsor's protocol ID
ICG318-001
Status last verified
Sep 2026
First submitted
17 Oct 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion in people with Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), run by iCell Gene Therapeutics at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Adam Chowdhury, MD, MBA (2404238999, Adam.Chowdhury@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Adverse Events after ICG318 infusion (time frame: Starting day 0 and up to 1 year after ICG318 infusion.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07328581.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.

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