Health Trials

About this trial

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.

Eligibility criteria

Qualifiers

Participants must agree to use protocol-specified method(s) of contraception where applicable

Diagnosed with MS according to the 2017 revision of the McDonald diagnostic criteria

Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high efficacy disease-modifying therapy (DMT) OR Inadequate response to previous therapies defined as intolerance to ≥ 2 DMTs due to side effects prohibiting the chronic use of the DMT.

Expanded Disability Status Scale (EDSS) 0 to 5.5

Disqualifiers

History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or cause weakness

History of autologous or allogeneic stem cell transplant and/or organ transplant

Cohort 1 or 2; inability to complete 9-hole Peg Test (9-HPT) in < 240 seconds and Timed 25 foot Walk (T25FW) < 150 seconds

History of hypersensitivity to parenteral administration of gadolinium-based contrast agents

Trial design

Treatments tested in this trial

  • KITE-363
  • Fludarabine
  • Cyclophosphamide

Treatment groups

52 Participants
are divided into 2 treatment groups

Locations

6
Australia
Concord Repatriation General Hospital2139, SydneyNew South Wales, Australia
Corner Hawkesbury Road and Darcy Road2145, WestmeadNew South Wales, Australia
United States
Stanford Neuroscience Health Center94304, Palo AltoCalifornia, United States
Columbia University Irving Medical Center10032, New YorkNew York, United States

Sponsors and collaborators

Kite, A Gilead Company

Lead sponsor

Source ClinicalTrials.gov