Ignite Creation Date:
2024-05-06 @ 2:47 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04422912
Status:
RECRUITING
Last Update Posted:
2024-05-22
First Post:
2020-06-02
Brief Title:
A Phase 12 Open-label Safety and Dosing Study of Autologous CART Cells Desmoglein 3 Chimeric Autoantibody Receptor T Cells DSG3-CAART or CD19-specific Chimeric Antigen Receptor T Cells CABA-201 in Subjects With Active Pemphigus Vulgaris RESET-PV
Sponsor:
Cabaletta Bio
Organization:
Cabaletta Bio
Study Overview
Official Title:
A Phase 12 Open-label Safety and Dosing Study of Autologous CART Cells Desmoglein 3 Chimeric Autoantibody Receptor T Cells DSG3-CAART or CD19-specific Chimeric Antigen Receptor T Cells CABA-201 in Subjects With Active Pemphigus Vulgaris
Status:
RECRUITING
Status Verified Date:
2024-08
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:
A phase 12 open-label safety and dosing study of autologous CART cells desmoglein 3 chimeric autoantibody receptor T cells DSG3-CAART or CD19-specific Chimeric Antigen Receptor T cells CABA-201 in subjects with active pemphigus vulgaris
Detailed Description:
Pemphigus vulgaris PV is a B-cell mediated autoimmune disorder in which painful blisters are formed on the skin or mucosal membrane including the mouth nose throat eyelids anus and genitals This phase 12 study is being conducted to find the maximum tolerated dose and optimal fractionated infusion schedule of an investigational cell therapy DSG3-CAART that can be given to patients with mucosal PV who are inadequately managed by standard therapies A sub-study will be conducted to investigate if CABA-201 can be safely administered while achieving clinical responses without the need for preconditioning in PV patients DSG3-CAART or CABA-201 may potentially lead to complete and durable remission of disease
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