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

NCT ID: NCT07038447

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE1
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-02
• Study Completion Date: 2029-07-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phase 1a: KITE-363 (Dose Escalation)

Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by 2 dose escalations of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose.

Group Type: EXPERIMENTAL

KITE-363

Intervention Type: BIOLOGICAL

A single infusion of CAR-transduced autologous T cells administered intravenously

Fludarabine

Intervention Type: DRUG

Administered intravenously

Cyclophosphamide

Intervention Type: DRUG

Administered intravenously

Phase 1b: KITE-363 (Dose Expansion)

Participants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1ab recommended dose of KITE-363 CAR T cells.

Group Type: EXPERIMENTAL

KITE-363

Intervention Type: BIOLOGICAL

A single infusion of CAR-transduced autologous T cells administered intravenously

Fludarabine

Intervention Type: DRUG

Administered intravenously

Cyclophosphamide

Intervention Type: DRUG

Administered intravenously

Interventions

KITE-363

A single infusion of CAR-transduced autologous T cells administered intravenously

Intervention Type: BIOLOGICAL

Fludarabine

Administered intravenously

Intervention Type: DRUG

Cyclophosphamide

Administered intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

• 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 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.

• 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).

• Adequate hepatic, renal, pulmonary, and cardiac function.

Exclusion Criteria

• 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.

• Significant pre-existing damage or rapidly progressive glomerulonephritis (GN).

• Drug-induced SLE.
• Catastrophic antiphospholipid syndrome.
• Thrombotic thrombocytopenic purpura.
• Active or unstable lupus neuropsychiatric manifestations within last 6 months.

• 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.

• Other inflammatory and noninflammatory myopathies.
• Severe, irreversible muscle damage.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kite, A Gilead Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kite Study Director

Role: STUDY_DIRECTOR

Kite, A Gilead Company

Locations

City of Hope

Duarte, California, United States

Stanford University

Stanford, California, United States

Concord Repatriation General Hospital

Syndey, New South Wales, Australia

St Vincent's Hospital

Fitzroy, Victoria, Australia

Jewish General Hospital

Montreal, , Canada

Countries

United States; Australia; Canada

Related Links

https://www.gileadclinicaltrials.com/study?nctid=NCT07038447

Gilead Clinical Trials Website

Other Identifiers

KT-US-720-0203

Identifier Type: -

Identifier Source: org_study_id