A Study of KITE-363 in Participants With Refractory Autoimmune Diseases

Launched by KITE, A GILEAD COMPANY · Jun 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called KITE-363 to see if it is safe and helpful for people with certain autoimmune diseases that have not responded well to other treatments. These diseases include lupus (a condition where the immune system attacks the body), lupus affecting the kidneys, systemic sclerosis (which causes skin and lung problems), and idiopathic inflammatory myopathy (a group of conditions causing muscle inflammation). The study will start by finding a safe dose of the drug and then will look more closely at how well it works and how safe it is.

People who might be eligible to join are adults who have been diagnosed with one of these autoimmune diseases and whose condition has not improved with standard treatments. For example, in lupus, patients need to have moderate to severe disease activity and specific antibodies in their blood. Participants must also have good overall organ function and not have certain other health issues like active infections, recent cancer, or pregnancy. If you join the study, you will receive the study drug and be closely monitored for side effects and any improvements in your condition. This study is not yet recruiting, but it aims to help find new treatment options for people with difficult-to-treat autoimmune diseases.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria:
• Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN):
• • Age ≥ 18 and ≤ 75 years
• • Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE
• • Presence of either double-stranded deoxyribonucleic acid (DNA) anti- double-stranded DNA (anti-dsDNA) and/or anti-Smith antibodies at screening per local laboratory.
• • Moderate to severe, active disease defined as at least one British Isles Lupus Assessment Group (BILAG-A) score or 2 BILAG B (excluding constitutional and/or neuropsychiatric organ system).
• • Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, anifrolumab, rituximab, obinutuzumab, methotrexate, azathioprine, cyclosporin, tacrolimus, or voclosporin.
• • For LN: Refractory to steroids and inadequate response or intolerance to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolate mofetil or its derivatives, belimumab, rituximab, obinutuzumab, azathioprine, cyclosporin, tacrolimus, or voclosporin
• Inclusion Criteria for LN:
• • Renal biopsy-proven Class III or intravenous (IV) ± V LN according to the revised International Society of Nephrology and Renal Pathology Society (ISN/RPS) criteria within 6 months prior to or during screening
• • Evidence of active LN at screening
• Inclusion Criteria for systemic sclerosis (SSc):
• • Age ≥ 18 and ≤ 60 years
• • Early systemic sclerosis according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive ILD
• • Refractory or intolerance to 1 of the following for a minimum of 3 months and/or contraindication: mycophenolate mofetil or its derivatives, methotrexate, tocilizumab (or other IL-6 inhibitor), rituximab (or other B-cell depleting agent), nintedanib (or other antifibrotic agents), cyclophosphamide.
• • High-resolution computer tomography (HRCT) scan and pulmonary function test (PFT) within 3 months prior to screening to evaluate for presence of SSc-ILD.
• Inclusion Criteria for idiopathic inflammatory myopathy (IIM):
• • Age ≥ 18 years
• • IIM based on EULAR/ACR 2017 classification (excluding inclusion body myositis).
• • Active disease demonstrated by electromyography (EMG). Magnetic resonance imaging (MRI) or muscle enzyme
• • Moderate to severe disease activity
• • Positive for myositis specific antibodies for patients with non-dermatomyostitis IIM
• • HRCT scan and PFT within 3 months prior to screening to evaluate for presence of IIM-ILD.
• • Refractory or intolerance to at least 1 month of glucocorticoids and standardized use of at least 2 immunosuppressant/modulator (eg, intravenous gamma globulins, methotrexate, mycophenolate mofetil and its derivatives, azathioprine, cyclophosphamide, calcineurin inhibitors, Janus kinase (JAK) inhibitors, rituximab or other B-cell depleting agent).
• Inclusion Criteria for all Cohorts:
• • Adequate hepatic, renal, pulmonary, and cardiac function.
• Key Exclusion Criteria:
• Exclusion Criteria for all Cohorts:
• • Females of childbearing potential who are pregnant or breast feeding.
• • Dialysis within the past year.
• • History of malignancy, within the last 5 years.
• • Hypogammaglobulinemia requiring immunoglobulin replacement.
• • History of autologous or allogeneic stem cell transplant and/or organ transplant.
• • Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy.
• • Known history of HIV infection, or hepatitis B or C virus infections.
• • Active or untreated latent tuberculosis (TB).
• • Active or uncontrolled infections.
• • Nonspecific, overlap, mixed autoimmune diseases not clearly identified into any of the studied cohorts.
• Exclusion Criteria for LN:
• • Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).
• Exclusion Criteria for SLE:
• • Drug-induced SLE.
• • Catastrophic antiphospholipid syndrome.
• • Thrombotic thrombocytopenic purpura.
• • Active or unstable lupus neuropsychiatric manifestations within last 6 months.
• Exclusion Criteria for SSc:
• • Digital ulceration or necrosis with infection.
• • Severe pulmonary hypertension.
• • History of systemic sclerosis renal crisis within 12 months prior to enrollment.
• • History of active bleeding related to gastric antral vascular ectasia.
• Exclusion Criteria for IIM:
• • Other inflammatory and noninflammatory myopathies.
• • Severe, irreversible muscle damage.
• • Note: Other protocol defined Inclusion/Exclusion criteria may apply.