Tests KITE-363 cell therapy in people with hard-to-treat autoimmune diseases
Tests KITE-363, a modified immune cell therapy, in adults with lupus or related diseases.
Plain-language title generated from the registry record
Registry title: A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
Key facts
- Where
- Fitzroy and Syndey, AustraliaSee the 2 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with lupus (with or without kidney involvement), systemic sclerosis, or idiopathic inflammatory myopathy whose disease is active and has not responded to earlier treatments.
- Age
- 18 years or older
- Sex
- Women and men can join
- Disease stage
- Moderate to severe active disease. Lupus: at least one BILAG-A score or 2 BILAG B scores. Lupus nephritis: biopsy-proven Class III or IV (± V) with active disease. Systemic sclerosis: diffuse type with active skin disease and/or progressive lung disease, or limited type with progressive lung disease. Myopathy: probable or definite, with active disease and moderate to severe activity.
- Earlier treatment
- Disease must not have responded to, or the person could not tolerate, earlier treatments. Lupus: steroids plus at least 2 listed medicines, each used for at least 3 months. Systemic sclerosis: at least 1 listed medicine for at least 3 months. Myopathy: at least 1 month of glucocorticoids and at least 2 immune-suppressing medicines.
- Biomarker or test result
- Lupus: specific autoantibodies as set out in the trial protocol. Myopathy (not dermatomyositis): positive for myositis-specific antibodies.
Main reasons for not taking part
- Pregnant or breastfeeding women who could have children
- Dialysis within the past year
- Cancer within the last 5 years
- Earlier stem cell or organ transplant, or earlier cell, gene or T-cell engager therapy
- HIV, hepatitis B or C, active or untreated latent tuberculosis, or other active infection
Read by machine on 9 November 2026.
Where in Australia
- St. Vincent's HospitalFitzroy, AustraliaNo longer taking part
- Concord Repatriation General HospitalSyndey, AustraliaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Kite, A Gilead Company
- Trial code
- NCT07038447
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants With Refractory Autoimmune Diseases
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.
Inclusion: Age ≥ 18 years; Meet the European Alliance of Associations for Rheumatology (EULAR)- American College of Rheumatology (ACR) 2019 classification criteria for SLE; Presence of autoantibodies as specified in the protocol; 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; 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; 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; 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); Adequate hepatic, renal, pulmonary, and cardiac function.
Exclusion: Prior treatment with cellular therapy, gene therapy and/or T-cell engager therapy; Drug-induced SLE; History of systemic sclerosis renal crisis within 12 months prior to enrollment; History of malignancy, within the last 5 years; History of autologous or allogeneic stem cell transplant and/or organ transplant; 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; Catastrophic antiphospholipid syndrome; Infected digital ulceration or necrosis with signs of infection; Severe pulmonary hypertension; History of active bleeding related to gastric antral vascular ectasia; Females of childbearing potential who are pregnant or breast feeding; Dialysis within the past year; Hypogammaglobulinemia requiring immunoglobulin replacement; Significant pre-existing damage or rapidly progressive glomerulonephritis (GN); Thrombotic thrombocytopenic purpura; Active or unstable lupus neuropsychiatric manifestations within last 6 months; Other inflammatory and noninflammatory myopathies; Severe, irreversible muscle damage; Note: Other protocol defined Inclusion/Exclusion criteria may apply.