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

ConditionsChronic Inflammatory Demyelinating PolyneuropathyMyasthenia GravisMultiple Sclerosis
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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • KITE-363

    Biological/Vaccine

    A single infusion of CAR-transduced autologous T cells administered as intravenous infusion.

  • Fludarabine

    Drug

    Administered intravenously

  • Cyclophosphamide

    Drug

    Administered intravenously

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Phase 1a: KITE-363 (Dose Escalation)Experimental treatment 3 interventions
Group B: Phase 1b: KITE-363 (Dose Expansion)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Phase 1a: Percentage of Participants Experiencing Treatment-emergent Adverse Event (TEAEs)

Time frame
Up to 2 years
2

Phase 1a: Percentage of Participants Experiencing Dose-limiting Toxicities (DLTs) After the Infusion of KITE-363

Time frame
Up to 28 days
3

Phase 1b: (All Cohorts) Percentage of Participants Experiencing TEAEs

Time frame
Up to 2 years
4

Phase 1b: Relapsing Forms of MS (RRMS) and (aSPMS): Number of New T1 Gadolinium Enhancing (GadE+) Lesions on Magnetic Resonance Imaging (MRI) at Week 12

This will be reported in participants with relapsing forms of Multiple Sclerosis MS (RRMS) and (aSPMS).

Time frame
Week 12

Secondary outcomes

1

Relapsing forms of MS (RRMS and aSPMS): Annual Relapse Rate

Proportion of participants with annual relapse.

Time frame
Up to 2 years
2

Relapsing Forms of MS (RRMS and aSPMS): Proportion of Participants With CDP-12

Time frame
Up to 2 years
3

Relapsing Forms of MS (RRMS and aSPMS): Proportion of Participants With CDP-24

Time frame
Up to 2 years
4

Relapsing Forms of MS (RRMS and aSPMS): Time to Onset of CDP-12

Time frame
Up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kite, A Gilead Company

Lead sponsor

Source ClinicalTrials.gov
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