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

NCT07328581 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: ICG318-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 4

Brief 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. Participants will receive protocol-specified lymphodepletion followed by ICG318 at the recommended Phase 2 dose.

Conditions

Systemic Lupus Erythematosus (SLE); Lupus Nephritis (LN)

Keywords

Lupus; autoimmune disease; CAR-T Cell; Refractory disease; CD19; BCMA; Lupus Nephritis (LN); Systemic Lupus Erythrematosus (SLE)

Outcome Measures

Primary Outcomes (2)

• 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).

  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).

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

Secondary Outcomes (14)

• Determine the recommended phase 2 dose (RP2D) regimen.

  Starting day 0 and assessed 1 year after ICG318 infusion.

• Cmax

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

• Tmax

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

• T1/2

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

• AUC

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

Study Arms (1)

Single arm

EXPERIMENTAL

Biologic drug infusion

Biological: ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion

Interventions

ICG318, BCMA-CD19-IL-15/IL-15 sushi Compound CAR T following lymphodepletion BIOLOGICAL

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

Single arm

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• iCell Gene Therapeutics: lead

Study Sites (4)

University of Chicago

Chicago, Illinois, 60637, United States

NOT YET RECRUITING

New York Medical College

Hawthorne, New York, 10532, United States

NOT YET RECRUITING

NorthWell

New Hyde Park, New York, 11040, United States

RECRUITING

Fox Chase Cancer Center- Temple BMT

Philadelphia, Pennsylvania, 19111, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic; Lupus Nephritis; Autoimmune Diseases; Disease

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Adam Chowdhury, MD, MBA

CONTACT

2404238999; Adam.Chowdhury@icellgene.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2025
• First Posted: January 9, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)