Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06350110
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-04-01
Brief Title:
Fourth-gen CAR T Cells Targeting BCMACD19 for Refractory Systemic Lupus Erythematosus SLE
Sponsor:
Essen Biotech
Organization:
Essen Biotech
Study Overview
Official Title:
T-cell Infusion Targeting BCMA and CD19 for RefractoryRelapsed Systemic Lupus Erythematosus SLE Patients With or Without Organs Involvement
Status:
RECRUITING
Status Verified Date:
2024-10
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:
BAH242
Brief Summary:
This study is a preliminary investigation with a single-group design not randomized and transparent focusing on treatment Its purpose is to identify the highest dose of BH002 injection CD19-BCMA CAR-T cells that patients suffering from resistant systemic lupus erythematosus can tolerate
Detailed Description:
Systemic lupus erythematosus SLE is a type of autoimmune disorder characterized by the creation of autoantibody-generating immune complexes affecting various systems and organs
In SLE autoreactive B cells can self-activate and morph into plasma cells that produce a high volume of autoantibodies These cells can also expose their own antigens to autoimmune T cells thereby stimulating T cells and leading to the release of inflammatory substances
Conventional treatment for SLE focuses on achieving prolonged remission In contrast CD19-BCMA CAR-T cells offer a potential solution by eradicating the abnormal B cells responsible for antibody production This allows for the rebuilding of the immune system and the restoration of normal immune function in patients potentially leading to a life free from medication This highlights the promising potential of CAR-T therapy in treating SLE
In SLE autoreactive B cells can self-activate and morph into plasma cells that produce a high volume of autoantibodies These cells can also expose their own antigens to autoimmune T cells thereby stimulating T cells and leading to the release of inflammatory substances
Conventional treatment for SLE focuses on achieving prolonged remission In contrast CD19-BCMA CAR-T cells offer a potential solution by eradicating the abnormal B cells responsible for antibody production This allows for the rebuilding of the immune system and the restoration of normal immune function in patients potentially leading to a life free from medication This highlights the promising potential of CAR-T therapy in treating SLE
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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