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

NCT07304154 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2026-04-21

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • Kite, A Gilead Company

    lead INDUSTRY

Principal Investigators

  • Kite Study Director · Kite, A Gilead Company

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-10
Primary Completion
2029-06-30
Completion
2029-06-30
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07304154 on ClinicalTrials.gov