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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

2026-04-10

Completion Date

2029-06

Last Updated

2026-07-01

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

Locations (6)

Stanford Neuroscience Health Center

Palo Alto, California, United States

Columbia University Irving Medical Center

New York, New York, United States

LDS Hospital - Intermountain Health

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Concord Repatriation General Hospital

Sydney, New South Wales, Australia

Corner Hawkesbury Road and Darcy Road

Westmead, New South Wales, Australia