A Study Evaluating the Safety and Efficacy of KITE-363 in Relapsed/Refractory Autoimmune Neurologic Diseases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorKite, A Gilead Company
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 groupsSponsors and collaborators
Source ClinicalTrials.gov