Ignite Creation Date:
2024-05-06 @ 8:22 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06359041
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-03-21
Brief Title:
RESET-MG A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis
Sponsor:
Cabaletta Bio
Organization:
Cabaletta Bio
Study Overview
Official Title:
RESET-MG A Phase 12 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells CABA-201 in Participants With Generalized Myasthenia Gravis
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RESET-MG A Phase 12 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis
Detailed Description:
Myasthenia gravis MG is a rare autoimmune disorder characterized by autoantibody responses that cause defective transmission of signals at the neuromuscular junction resulting in a distinctive pattern of weakness Patients with generalized MG gMG typically experience symptoms associated with ocular disease in addition to weakness of many other voluntary muscle groups including extremity bulbar and respiratory muscles MG is considered a classic example of a B-cell mediated autoimmune disease Currently there are no curative treatments for MG This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy CABA-201 that can be given to patients with gMG A single dose of CABA-201 in combination with cyclophosphamide CY and fludarabine FLU will be evaluated
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None