Tests KITE-363 cell therapy in people with hard-to-treat autoimmune diseases

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.

ClinicalTrials.gov NCT07038447