KITE-363 in Human Participants with Autoimmune Neurologic Diseases
This Phase 1 study aims to evaluate the safety and tolerability of KITE-363, a CAR T-cell therapy, in participants with autoimmune neurologic diseases such as multiple sclerosis and myasthenia gravis. The study will also determine a recommended dose for subsequent trials and assess preliminary efficacy. However, no conclusive results are available as the trial has not posted any outcomes yet.
- Tags
- #MSResearch
- Most relevant to
- —
- Source
- Read original source
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
Understanding the safety and dose of KITE-363 is crucial for advancing its use in treating complex autoimmune conditions. As autoimmune neurologic diseases can be challenging to treat, data from this study may inform future therapies.
What this does not prove
No results are shared in the registry, preventing any conclusions about the study's efficacy or safety outcomes. Details like sample size and specific results are unknown.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Not reported
- Participants / samples
- Not reported
- Randomised
- No
- Controlled
- Not reported
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- Not reported
- Research areas
- Not classified
Original sources
Supporting passages (7)
findingsThe 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.\n\nThe primary objectives of this study are:\n\n* To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases\n* To determine the recommended dose for Phase 1b\n* To evaluate the safety and preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases"
study phase"officialTitle": "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 Relapsed/Refractory Autoimmune Neurologic Diseases",
subjectsThis study will have two Phases: Phase 1a and Phase 1b.
species"description": "Participants with relapsing forms of multiple sclerosis (RMS), progressive forms of multiple sclerosis (PMS), myasthenia gravis (MG), and/or chronic inflammatory demyelinating polyneuropathy (CIDP) will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine followed by infusion of KITE-363 chimeric antigen receptor (CAR) transduced autologous T cells at a single dose level, with different participants receiving sequential dose-escalation levels to find the Phase 1b recommended dose.",
randomized"allocation": "NON_RANDOMIZED",
primary endpointThe 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.\n\nThe primary objectives of this study are:\n\n* To evaluate the safety and tolerability of KITE-363 in participants with autoimmune neurologic diseases\n* To determine the recommended dose for Phase 1b\n* To evaluate the safety and preliminary efficacy of KITE-363 in participants with autoimmune neurologic diseases"
limitationsTrial registry record. Publication date: unknown. No results are posted. Planned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.