Clinical trial for Chronic Inflammatory Demyelinating Polyneuropathy
Official title Study of KITE-363 in Participants With Autoimmune Neurologic Diseases That Did Not Respond to Usual Treatment
ClinicalTrials.gov ID: NCT07304154
What this study is testing
What is KITE-363?
KITE-363 is an investigational cellular therapy being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to check if the drug is safe and to find the right dose for future testing.
- Who it's for
- People with specific nerve conditions, such as multiple sclerosis or myasthenia gravis, that have not improved with standard treatments.
- What's involved
- Participants will receive the study drug and undergo medical tests to monitor their health and how their body reacts to the treatment.
- Time commitment
- The study has two parts, but the source text does not specify the total duration or number of visits.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Age 18 through 65 for relapsing forms of MS, 18 through 75 for progressive forms of MS, above 18 years of age for MG and CIDP.
- Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high...
- Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care...
- Absence of clinical relapses for at least 24 months
- No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline
You likely can't join if
- History or presence of central nervous system (CNS) or peripheral nervous system disorders before enrollment that may impact cognition, strength, or...
- 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
- Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)
- Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
See the full eligibility criteria
- Age 18 through 65 for relapsing forms of MS, 18 through 75 for progressive forms of MS, above 18 years of age for MG and CIDP.
- Inadequate response to previous therapies is defined as evidence of breakthrough disease activity within 12 months prior to screening while on high how well it works disease-modifying therapy (DMT) OR Inadequate...
- Inadequate response to previous therapies is defined as evidence of disease progression within 12 months prior to screening despite standard of care therapy for naSPMS or despite ocrelizumab, where available, for PPMS
- Absence of clinical relapses for at least 24 months
- No evidence of Gadolinium enhancing (GadE+) on magnetic resonance imaging (MRI) brain at screening or baseline
- Documentation of autoantibodies against acetylcholine receptor (AChR), muscle-specific kinase (MuSK), or low-density lipoprotein receptor-related protein 4 (LRP4)
- Diagnosis of MG with generalized weakness meeting criteria as defined by the Myasthenia Gravis Foundation of American (MGFA) classification of II- IV at screening
- Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6 (\> 50% of the total score due to non-ocular symptoms)
- Quantitative Myasthenia Gravis (QMG) score ≥ 10
- Inadequate response to previous therapies while taking at least 2 classes of immunosuppressants (ie, steroids, azathioprine (AZA), mycophenolate mofetil (MMF), intravenous immunoglobulin (IVIg), biologics (eg...
- Probable or definite CIDP as defined by the 2010 European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) criteria, relapsing or progressive forms.
- For the Phase 1b CIDP cohort, diagnosis will be confirmed by independent adjudication once the adjudication committee is established and operational
- CIDP Disease Activity Status (CDAS) score ≥ 3 at screening and confirmed at the final pre treatment assessment prior to infusion
- Inflammatory neuropathy cause and treatment (INCAT) score ≥ 3 at screening and confirmed at one of more protocol-defined baseline assessments during the Extended Screening Period with Observational Run-in
- Inadequate response to previous therapies despite adequate trial of standard of care therapy (≥ 8-12 weeks at standard dosing with stable regimen of either steroids, IVIg, SCIg, plasmapheresis exchange (PLEX), rituximab...
- Except for nodal/paranodal CIDP, historical documentation of objective improvement in the past 24 months while on IVIg, SCIg, PLEX, or anti-FcRN OR Historical documentation of objective disease worsening in the past 24...
- 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
- Any renal condition that would preclude the administration of gadolinium (for the relapsing forms of MS and progressive forms of MS)
- Current myasthenic crisis not effectively controlled within 2 weeks before enrollment
- Pure sensory CIDP and focal CIDP
- Polyneuropathy of other causes Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Newport Beach, California, United States
- Palo Alto, California, United States
- New York, New York, United States
- Salt Lake City, Utah, United States
- Seattle, Washington, United States
- Sydney, New South Wales, Australia
- Westmead, New South Wales, Australia
- Montreal, Canada
- Ottawa, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Newport Beach, California, United States; Palo Alto, California, United States; New York, New York, United States; Salt Lake City, Utah, United States; Seattle, Washington, United States; Sydney, New South Wales, Australia and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.