Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06588491
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-06
Brief Title:
KYSA-8 A Study of Anti-CD19 Chimeric Antigen Receptor T-Cell CD-19 CAR T Therapy in Subject With Treatment Refractory Stiff Person Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
KYSA-8 A Phase 2 Open-Label Single-Arm Multicenter Study of KYV 101 an Autologous Fully Human Anti-CD19 Chimeric Antigen Receptor T Cell CD19 CAR T Therapy in Subjects With Treatment Refractory Stiff Person Syndrome
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Study of Anti-CD19 Chimeric Antigen Receptor T Cell Therapy for Subjects With Treatment Refractory Stiff Person Syndrome
Detailed Description:
Stiff person syndrome SPS is a rare progressive immune-mediated disorder of the central nervous system CNS that is characterized by progressive rigidity and painful spasms of predominantly axial and proximal limb muscles The condition gradually worsens over time and left untreated it can lead to permanent disability and in some cases mortality
B cells contribute to systemic autoimmunity and development of disease in several ways most notably via cytokine production antigen presentation and complement activation via autoantibody production In SPS B cell involvement is supported by the presence of antibodies against glutamic acid decarboxylase GAD which is widely expressed within the CNS catalyzing the conversion of the excitatory neurotransmitter l-glutamate to the inhibitory GABA
CAR-T therapy such as KYV-101 may be an effective treatment for SPS by targeting these autoreactive B cells Using chimeric antigen receptor CAR T-cell technology engineered T cells with receptors are designed to recognize and eliminate B cells including those that produce GAD autoantibodies This approach aims to intervene at the root of the autoimmune response offering a precise and potentially transformative treatment for SPS CAR-T cell therapy holds promise as a targeted and effective intervention addressing the autoimmune component directly and potentially halting disease progression
B cells contribute to systemic autoimmunity and development of disease in several ways most notably via cytokine production antigen presentation and complement activation via autoantibody production In SPS B cell involvement is supported by the presence of antibodies against glutamic acid decarboxylase GAD which is widely expressed within the CNS catalyzing the conversion of the excitatory neurotransmitter l-glutamate to the inhibitory GABA
CAR-T therapy such as KYV-101 may be an effective treatment for SPS by targeting these autoreactive B cells Using chimeric antigen receptor CAR T-cell technology engineered T cells with receptors are designed to recognize and eliminate B cells including those that produce GAD autoantibodies This approach aims to intervene at the root of the autoimmune response offering a precise and potentially transformative treatment for SPS CAR-T cell therapy holds promise as a targeted and effective intervention addressing the autoimmune component directly and potentially halting disease progression
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None