Ignite Creation Date:
2024-06-16 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06428188
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-20
Brief Title:
Sequential CAR-T Cells Targeting BCMACD19 in Patients With Relapsed Refractory Autoimmune Diseases
Sponsor:
Essen Biotech
Organization:
Essen Biotech
Study Overview
Official Title:
Sequential CAR-T Cells Targeting BCMACD19 in Patients With Relapsed Refractory Autoimmune Diseases
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:
BAH247
Brief Summary:
This is an open single-arm clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy CAR-T targeting BCMA or CD19 or both sequentially in the treatment of Relapsed Refractory Autoimmune Disease such as Sjogrens Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease
Detailed Description:
Chimeric antigen receptor CAR-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies Besides CD19 many other molecules such as CD22 CD30BCMACD123 etc may have the potential to develop the corresponding CAR-T cells to treat patients whose tumors express those markers In this study investigators will evaluate the safety and efficacy of CAR-T targeting CD19BCMA in patients with Autoimmune Disease The primary goal is safety assessment including cytokine storm response and any other adverse effects In addition disease status after treatment will also be evaluated
The purpose of this clinical trial is to assess the feasibility safety and efficacy of multiple CAR T-cell therapy that combines CAR T cells against Autoimmune Disease B Cells with CAR T cells targeting BCMA or CD19 or both in patients with relapsed and refractory Autoimmune Disease The study also aims to learn more about the function of CAR T cells and their persistence in Autoimmune Disease patients
The purpose of this clinical trial is to assess the feasibility safety and efficacy of multiple CAR T-cell therapy that combines CAR T cells against Autoimmune Disease B Cells with CAR T cells targeting BCMA or CD19 or both in patients with relapsed and refractory Autoimmune Disease The study also aims to learn more about the function of CAR T cells and their persistence in Autoimmune Disease patients
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