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ENROLLING BY INVITATION
NCT07038447
PHASE1

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

Sponsor: Kite, A Gilead Company

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

52

Start Date

2025-07-02

Completion Date

2029-07

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

BIOLOGICAL

KITE-363

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

DRUG

Fludarabine

Administered intravenously

DRUG

Cyclophosphamide

Administered intravenously

Locations (6)

City of Hope

Duarte, California, United States

Stanford University

Stanford, California, United States

Concord Repatriation General Hospital

Sydney, New South Wales, Australia

St Vincent's Hospital

Fitzroy, Victoria, Australia

Jewish General Hospital

Montreal, Canada

The Ottawa Hospital, General Campus

Ottawa, Canada