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

Part of paid clinical trials in Duarte, California.

Sponsor
Kite, A Gilead Company
Study ID
NCT07038447
Phase
PHASE1
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KITE-363 — BIOLOGICAL
    A single infusion of CAR-transduced autologous T cells administered intravenously
  • Fludarabine — DRUG
    Administered intravenously
  • Cyclophosphamide — DRUG
    Administered intravenously

Study Details

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.

Key Dates

Start date
Jul 2, 2025
Status verified
Jun 2026
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
52 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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.
  • Experimental: 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.

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 ]

Locations (4)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010-
Stanford UniversityStanfordCalifornia94305-
Tampa General Hospital Cancer InstituteTampaFlorida33606-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-

Find similar trials in Duarte, CA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
City of Hope· Duarte, CAStanford University· Stanford, CATampa General Hospital Cancer Institute· Tampa, FLIcahn School of Medicine at Mount Sinai· New York, NY

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