Study of Kite-363 in participants with difficult to treat autoimmune diseases, evaluating efficacy and safety.
A Phase 1, Open-Label, Multiregional, Multicenter, Basket Study Evaluating the Safety & Efficacy of Kite-363, an Autologous Anti-CD19-CD20 CAR T-Cell Therapy in Participants with Refractory Autoimmune Diseases
Kite, A Gilead Company
52 participants
Jul 30, 2025
Interventional
Conditions
Summary
KITE-363 is an exploratory treatment for chronic, moderate to severe autoimmune diseases such as systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and idiopathic inflammatory myopathies (IIM). KITE-363 utilizes a patient's own T-cells, which are genetically modified to target and eliminate pathogenic B-cells. By depleting these harmful cells, KITE-363 aims to reduce the effects of autoimmune diseases
Eligibility
Inclusion Criteria10
- Aged between 18 and 75 years
- Meet the EULAR-ACR 2019 classification criteria for SLE
- 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.
- Age between 18 and 60 years old
- Systemic sclerosis according to ACR/EULAR 2013 classification criteria
- Disease duration greater than 5 years
- 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
- Aged 18 years or over
- Idiopathic inflammatory myopathy (IIM) based on EULAR/ACR 2017 classification
- Active disease by electromyography (EMG) or magnetic resonance imaging (MRI) within 3 months of lymphodepletion
Exclusion Criteria17
- Females of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the preparative chemotherapy on the fetus or infant.
- Unstable cardiac disease within 12 months before enrollment:
- A) Cardiac ejection fraction < 50% via echocardiogram (ECHO) or multigated acquisition
- scan (MUGA)
- B) Haemodynamic instability secondary to large pericardial effusion or cardiac tamponade
- C) Unstable arrythmia, valvular dysfunction, myocarditis, coronary vasculitis, or clinically
- significant electrocardiogram (ECG) findings, and/or
- D) Myocardial infarction, cardiac angioplasty or stenting, unstable angina
- Clinically significant pulmonary disease within 12 months before enrollment:
- A) Baseline oxygen saturation < 92% on room air
- B) Pulmonary hemorrhage
- eGFR < 40 mL/min/1.73 m2 using the Chronic Kidney Disease (CKD) Epidemiology
- Collaboration (CKD-EPI) formula at screening
- Dialysis within the past year
- History of symptomatic deep vein thrombosis or pulmonary embolism requiring therapeutic anticoagulation within 6 months before enrollment
- 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
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Interventions
This is an open-label, basket study meaning this study includes participants who have been diagnosed with different illnesses but who will all receive the same treatment and have the same outcomes assessed. Safety and efficacy of Kite-363 will be evaluated in participants with Systemic Lupus Erythematosus with or without Lupus Nephritis; Systemic Sclerosis, or Idiopathic Inflammatory Myopathies. Participants will firstly undergo leukapheresis to obtain leukocytes, from which the participant’s T cells will be used to manufacture KITE-363. Participants will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to infusion of KITE-363. Treatment will consist of a single infusion of CAR-transduced autologous T cells (KITE-363) administered intravenously. The dose escalation levels for Kite 363 are as follows: 0.2 x 106, 0.5 x 106, 1.0 x 106 Kite-363 Cells/kg. Both the first and second cohorts of participants may include participants from any of the indicated diseases mentioned above. Up to 12 participants will be enrolled in the first cohort and will be treated at sequential dose-escalation levels and assessed for dose limiting toxicities (DLTs). Administration of Kite-363 will be staggered to allow for observation of toxicities. 4 weeks after the first cohort is dosed with 0.2 x 106 Kite-363 Cells/kg, if the dose limiting toxicities observed do not cross the study-specific thresholds then the next dose level (0.5 x 106 Kite-363 Cells/kg) cohorts will be dosed. Similarly, the 1.0 x 106 Kite-363 Cells/kg dose will be administered 4 weeks after the second dose level if dose limiting toxicities are not observed. Based on dose limiting toxicities (DLTs) observed in the first cohort of participants and in assessment of the recommended KITE-363 dose, additional participants will be enrolled and administered escalating doses of KITE-363 to further characterise the efficacy and safety profile. During this dose-expansion portion of the study, indication specific cohorts will also be used. Participants will be dosed at treatment centres, by medical staff specially trained on the product.
Locations(2)
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ACTRN12625000707460