A Study of KITE-363 in Participants With Refractory Autoimmune Diseases
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Key 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.
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:
- 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
52 participants in 2 patient groups
Trial contacts and locations
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Central trial contact
Medical Information
Data sourced from clinicaltrials.gov
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