A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases

Part of paid clinical trials in Palo Alto, California.

Sponsor
Kite, A Gilead Company
Study ID
NCT07304154
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

This study will have two Phases: Phase 1a and Phase 1b. The goals of this clinical study are to learn more about the study drug KITE-363, by evaluating its safety, tolerability and efficacy in participants with relapsed/refractory autoimmune neurologic diseases. The primary objectives of this study are: * To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases * To determine the recommended dose for Phase 1b. * To evaluate the preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases.

Key Dates

Start date
Apr 10, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 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 relapsing forms of multiple sclerosis (RMS), progressive forms of multiple sclerosis (PMS), myasthenia gravis (MG), and/or chronic inflammatory demyelinating polyneuropathy (CIDP) will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by infusion of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells at a single dose level, with different participants receiving sequential dose-escalation levels to find the Phase 1b recommended dose.
  • Experimental: Phase 1b: KITE-363 (Dose Expansion)
    Participants with RMS, PMS, MG, and/or CIDP will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed Phase 1a recommended dose of KITE-363 CAR T cells.

Primary Outcome Measure

Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs) [ Time Frame: Up to 2 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Stanford Neuroscience Health CenterPalo AltoCalifornia94304-
LDS Hospital - Intermountain HealthSalt Lake CityUtah84143-
Fred Hutchinson Cancer CenterSeattleWashington98109-

Find similar trials in Palo Alto, CA

By condition
Multiple sclerosis
By specialty
NeurologyBrain disordersAutoimmune disease
By research site
Stanford Neuroscience Health Center· Palo Alto, CALDS Hospital - Intermountain Health· Salt Lake City, UTFred Hutchinson Cancer Center· Seattle, WA

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