Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06569472
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Clinical Trial of CD19-targeted CAR-T Therapy for Refractory Juvenile Dermatomyositis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Study of CD19 Targeting Chimeric Antigen Receptor T Lymphocytes CAR-T in the Treatment of Refractory Juvenile Dermatomyositis RJDM
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This is a Phase I clinical trial to evaluate the efficacy and safety of CD19-targeted CAR-T in the treatment of refractory juvenile dermatomyositis RJDMThe experiment was divided into two phases dose exploration Part A and dose extension Part B
Detailed Description:
juvenile dermatomyositis JDM is a non-suppurative chronic autoimmune disease and the most common type of juvenile idiopathic inflammatory myopathyDespite the active treatment measures some JDM patients are still intolerant or unresponsive to the treatment resulting in a high disability and mortality rateBecause CD19 is widely expressed on the surface of B lymphocytes CD19 CAR-T can also cause deep depletion of other CD19 B cells while killing cancer cells which is expected to achieve immune reconstruction in patients with autoimmune diseases and completely change the status quo that such patients need to take hormones and immunosuppressants for a long time
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