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KITE-363 for Refractory Autoimmune Diseases

This study is testing KITE-363, a cell therapy given as a single infusion of specially prepared T cells (a type of immune cell), along with chemotherapy drugs fludarabine and cyclophosphamide. It aims to understand the safety, best dose, and how well KITE-363 works for people with severe autoimmune diseases like Systemic Lupus Erythematosus (SLE), Lupus Nephritis, Systemic Sclerosis, and Idiopathic Inflammatory Myopathy. To join, you must be at least 18 years old and meet specific criteria for your autoimmune condition, such as having certain antibodies (like anti-dsDNA or anti-Smith) if you have SLE. The study will look at side effects and how many participants achieve remission or low disease activity, especially for SLE, at 6 months.

Study design
This is an interventional study with two phases (Phase 1a and Phase 1b) and plans to enroll 52 participants. The specific phase is not mentioned, but it will evaluate safety and efficacy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 2 years to monitor for adverse events. For SLE, remission and low disease activity will be assessed at Month 6.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07038447

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

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
Kite, A Gilead Company
~52 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:KITE-363FludarabineCyclophosphamide

At a glance

Recruiting sites
0 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363
Measured over Up to 2 years
+6 more outcomes measured

Conditions

Systemic Lupus Erythematosus
Lupus Nephritis
Systemic Sclerosis
Idiopathic Inflammatory Myopathy

Explore related trials

Idiopathic Inflammatory MyopathyLupus GlomerulonephritisSystemic Lupus ErythematosusSystemic SclerodermaAnti-ds DNA AntibodyAnti-Smith Antibodymyositis specific antibodies

NCT07038447

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • City of Hope

    Duarte, Californiano site contact published

  • Concord Repatriation General Hospital

    Syndey, New South Wales, Australiano site contact published

  • Icahn School of Medicine at Mount Sinai

    New York, New Yorkno site contact published

  • Jewish General Hospital

    Montreal, Canadano site contact published

  • St Vincent's Hospital

    Fitzroy, Victoria, Australiano site contact published

  • Stanford University

    Stanford, Californiano site contact published

  • Tampa General Hospital Cancer Institute

    Tampa, Floridano site contact published

  • The Ottawa Hospital, General Campus

    Ottawa, Canadano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Kite Study Director · STUDY_DIRECTOR · Kite, A Gilead Company

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

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 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 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

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.
Infected digital ulceration or necrosis with signs of 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.

What this trial measures

  • Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363Up to 2 years
  • Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)Up to 2 years
  • Phase 1b: Systemic lupus erythematosus (SLE): Proportion of participants meeting DORIS remission and Lupus low Disease Activity State (LLDAS) criteria at Month 6Month 6
  • Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS RemissionMonth 6
  • Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6Month 6
  • Phase 1b: Systemic Sclerosis (SSc) Cohort: Proportion of Participants With Improvement in Disease Activity by the Revised Combined Response Index in Diffuse Cutaneous Systemic Sclerosis (rCRISS) at Month 6Month 6
  • Phase 1b: Idiopathic Inflammatory Myopathy (IIM): Proportions of Participants Meeting European League Against Rheumatism (EULAR)-American College of Rheumatology (ACR) Moderate and Major response 2016 Criteria in Total Improvement Score (TIS) at Month 6Month 6