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NOT YET RECRUITING
NCT07304154
PHASE1

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

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

Summary

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.

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 Relapsed/Refractory Autoimmune Neurologic Diseases

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2026-03

Completion Date

2029-06

Last Updated

2026-03-10

Healthy Volunteers

No

Interventions

BIOLOGICAL

KITE-363

A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.

DRUG

Fludarabine

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously