By InvitationPhase 1

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

United States, Australia, Canada52 participantsStarted 2025-07-02

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Key Inclusion Criteria: Inclusion Criteria for systemic lupus erythematosus (SLE) and lupus nephritis (LN): * 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 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 * Evidenc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this is a Phase 1 trial focused primarily on finding a safe dose and identifying side effects of KITE-363, what do we currently know about the risks, and how does that uncertainty compare to the standard treatments available for my specific condition?
2This trial is 'enrolling by invitation only' — what would it actually take for me to be considered, and is my care team connected to a site that could refer me?
3CAR-T cell therapies like KITE-363 typically involve a conditioning process before the infusion — what would the treatment schedule, hospitalization requirements, and recovery period realistically look like for me?
4For my specific diagnosis — whether it's lupus, lupus nephritis, systemic sclerosis, or inflammatory myopathy — the trial is measuring very different success targets at 6 months, so how does what they're trying to achieve in my disease category compare to what I might expect from continuing or switching my current therapy?
5Because this is an early-phase study, the focus is on safety first and early signals of benefit second — if I were to enroll and experience a serious adverse event, what would my options look like, and how would my ongoing care be managed?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363

Timeframe: Up to 2 years

Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)

Timeframe: 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 6

Timeframe: Month 6

Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission

Timeframe: Month 6

Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6

Timeframe: Month 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 6

Timeframe: Month 6

Trial details

NCT IDNCT07038447

SponsorKite, A Gilead Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-07

View on ClinicalTrials.gov More Systemic Lupus Erythematosus trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363

Timeframe: Up to 2 years

Phase 1b: All Cohorts Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)

Timeframe: 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 6

Timeframe: Month 6

Phase 1b: Lupus Nephritis (LN): Proportion of Participants Meeting DORIS Remission

Timeframe: Month 6

Phase 1b: LN: Proportion of Participants Achieving a Complete Renal Response at Month 6

Timeframe: Month 6