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Systemic Lupus ErythematosusPhase 1NCT07038447

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

A Phase 1 study testing KITE-363, Fludarabine and Cyclophosphamide in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Kite, A Gilead Company at 10 sites in 4 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
KITE-363, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
10 sitesin 4 countries
Study dates
2 Jul 2025to Sep 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 autoantibodies as specified in the protocol
  • 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.
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  • 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.
  • Inclusion Criteria for idiopathic inflammatory myopathy (IIM):
  • 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.

Who cannot join

  • 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.
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  • 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.
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

10 sites in 4 countries. Contact the study team or a site near you to ask about taking part.

10 sites in 4 countries

United States4 sites

  • City of Hope

    Duarte, California, 91010

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Stanford University

    Stanford, California, 94305

  • Tampa General Hospital Cancer Institute

    Tampa, Florida, 33606

Other trials in United States

Australia2 sites

  • St Vincent's Hospital

    Fitzroy, Victoria, 3065

  • Concord Repatriation General Hospital

    Syndey, New South Wales, 2139

Other trials in Australia

Canada2 sites

  • Jewish General Hospital

    Montreal, H3T1E2

  • The Ottawa Hospital, General Campus

    Ottawa, K1H 8L6

Other trials in Canada

South Korea2 sites

  • Seoul National University

    Seoul, 03080

  • Asan Medical Center

    Seoul, 138-736

Other trials in South Korea

About this study

Official title: A Phase 1 Open-label, Multiregional, Multicenter, Basket Study Evaluating the Safety and Efficacy of KITE-363, an Autologous Anti-CD19/CD20 CAR T-cell Therapy in Participants With Refractory Autoimmune Diseases

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.

Being tested
KITE-363, Fludarabine, Cyclophosphamide
Medical subject headings
Lupus Erythematosus, Systemic, Lupus Nephritis, Scleroderma, Systemic, Myositis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KITE-363Biological

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

  • FludarabineDrug

    Administered intravenously

  • CyclophosphamideDrug

    Administered intravenously

Study groups in NCT07038447
Study groupRoleWhat they receive
Phase 1a: KITE-363 (Dose Escalation)ExperimentalParticipants with refractory autoimmune diseases will receive lymphodepleting chemotherapy followed by different doses of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells to find the Phase 1b recommended dose.
Receives: Biological: KITE-363; Drug: Fludarabine; Drug: Cyclophosphamide
Phase 1b: KITE-363 (Dose Expansion)ExperimentalParticipants with refractory autoimmune diseases will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1a recommended dose of KITE-363 CAR T cells.
Receives: Biological: KITE-363; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 2 years

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

    Measured: Up to 2 years

  3. Phase 1b: Systemic lupus erythematosus (SLE): Proportion of participants meeting DORIS remission and Lupus low Disease Activity State (LLDAS) criteria at Month 6

    Measured: Month 6

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

    Measured: Month 6

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

    Measured: Month 6

  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

    Measured: Month 6

  7. 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 6

    Measured: Month 6

Secondary outcomes (11)

  1. Characterization of Product, Including T-cell Phenotype as Assessed by Percent Change From Baseline in cluster of differentiation 3 (CD3)+ Cells and T Cells

    Measured: Baseline up to 2 years

  2. Pharmacokinetic parameter: Serum Concentration of KITE-363 CAR T-cells

    Measured: Up to 2 years

  3. Pharmacokinetic parameter: Peak Concentration (Cmax) for KITE-363 CAR T-cells

    Measured: Up to 2 years

  4. Pharmacokinetic parameter: AUC for KITE-363 CAR T-cells

    AUC is defined as the area under the concentration time curve for KITE-363 CAR T-cells.

    Measured: Up to 2 years

  5. Pharmacokinetic parameter: Time to Peak Serum Concentration (Tmax) for KITE-363 CAR T-cells

    Measured: Up to 2 years

  6. Pharmacodynamic Parameters: Serum Concentration of Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors in blood over time

    Measured: Up to 2 years

  7. Pharmacodynamic Parameters: Peak Serum Concentration (Cmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors

    Measured: Up to 2 years

  8. Pharmacodynamic Parameters: AUC for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors

    AUC is defined as the area under the concentration time curve.

    Measured: Up to 2 years

  9. Pharmacodynamic Parameters: Time to Peak Serum Concentration (Tmax) for Pro-inflammatory and Immune-modulating Cytokines, Chemokines, and Effector molecules, Autoantibodies, Muscle Enzymes, and Complement factors

    Measured: Up to 2 years

  10. Percentage of Participants with Antibodies Against KITE-363 CAR T cells

    Measured: Up to 2 years

  11. Change from Baseline in Levels of B cells

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jun 2025
  2. Study start2 Jul 2025
  3. Primary completionSep 2030 (estimated)
  4. Study completionSep 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07038447
Sponsor's protocol ID
KT-US-720-0203
Status last verified
Sep 2026
First submitted
18 Jun 2025
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KITE-363, Fludarabine and Cyclophosphamide in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Kite, A Gilead Company at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Australia, Canada, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1a: Percentage of Participants Experiencing Adverse Events Defined as Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363 (time frame: Up to 2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07038447.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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