Study Details

PROTOCOL 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.

Participation Requirements

Age

18 Years - 75 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Systemic Lupus Erythematosus, Lupus Nephritis, Systemic Sclerosis, Idiopathic Inflammatory Myopathy

Gender

N/A

Date

July 2025 - July 2029

Study Type

INTERVENTIONAL

Study Phase

PHASE1

Product

KITE-363, Fludarabine, Cyclophosphamide

Eligibility Information

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.

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.

Locations

Locations (3)

City of Hope

Duarte, California, United States, 91010

Concord Repatriation General Hospital

Syndey, New South Wales, Australia, 2139

St Vincent's Hospital

Fitzroy, Victoria, Australia, 3065

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

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