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Clinical Trials in the USA / NCT07038447
Enrolling by invitation Phase 1

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

NCT07038447 · tracked via the Priya Life Science USA tracker
Sponsor
Kite, A Gilead Company
Phase
Phase 1
Started
2025-07-02
Last updated
2026-06-16

Condition(s) studied

Systemic Lupus ErythematosusLupus NephritisSystemic SclerosisIdiopathic Inflammatory Myopathy

Investigational drug(s) / intervention(s)

KITE-363FludarabineCyclophosphamide

KITE-363: A single infusion of CAR-transduced autologous T cells administered intravenously

Fludarabine: Administered intravenously

Cyclophosphamide: Administered intravenously

Study summary

This study will have two Phases: Phase 1a and Phase 1b. The goal of this clinical study is to learn more about the study drug KITE-363, to establish dosing, tolerability, safety, and preliminary efficacy of KITE-363 in participants with refractory autoimmune diseases.

The primary objectives of this study are:

Phase 1a: To evaluate the safety and tolerability of KITE-363 in participants with autoimmune disease. To determine the recommended dose for Phase 1b.

Phase 1b: To evaluate the safety and efficacy of KITE-363 in participants with autoimmune disease.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Key Inclusion Criteria: Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN): * Age ≥ 18 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 years * Diffuse Systemic Sclerosis (SSc) according to ACR/EULAR 2013 classification criteria with active skin disease and/or progressive SSc-interstitial lung disease (ILD) OR limited SSc with 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. Inclusion Criteria for idiopathic inflammatory myopathy (IIM): * Age ≥ 18 years * Probable or definite IIM based on EULAR/ACR 2017 classification (excluding inclusion body myositis). * Active disease demonstrated by electromyography (EMG), magnetic resonance imaging (MRI) or muscle enzymes * 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. * 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: * Infected digital ulceration or necrosis with signs of 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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
City of Hope Duarte California
Stanford University Stanford California
Tampa General Hospital Cancer Institute Tampa Florida
Icahn School of Medicine at Mount Sinai New York New York
Concord Repatriation General Hospital Syndey New South Wales
St Vincent's Hospital Fitzroy Victoria
Jewish General Hospital Montreal Canada
The Ottawa Hospital, General Campus Ottawa Canada

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07038447 on ClinicalTrials.gov ↗ ← All trials in the USA