Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06352281
Status:
RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-04-02
Brief Title:
Efficacy and Safety of CAR-T Cells Therapy for Chronic or Refractory Primary Immune Thrombocytopenia ITP
Sponsor:
920th Hospital of Joint Logistics Support Force of Peoples Liberation Army of China
Organization:
920th Hospital of Joint Logistics Support Force of Peoples Liberation Army of China
Study Overview
Official Title:
An Investigator-initiated Trial to Evaluate the Efficacy and Safety of CAR-T Cells Therapy in the Treatment of Chronic or Refractory Primary Immune Thrombocytopenia ITP
Status:
RECRUITING
Status Verified Date:
2024-07
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:
It is a single-center single-arm open-labeled clinical trial to evaluate the efficacy and safety of CAR-T cells therapy for Chronic or Refractory Primary Immune Thrombocytopenia ITP
Detailed Description:
This open label and single-arm study aims to evaluate the efficacy and safety of CAR-T cells therapy in patients with Chronic or Refractory Primary Immune Thrombocytopenia ITP After enrollment a leukapheresis procedure will be performed to manufacture chimeric antigen receptor CAR modified T cells Patients will get a 3-5 days lymphodepletion therapy with fludarabine and cyclophosphamide then the CAR-T cells will be infused by vein After infusion subjects will be followed for safety and efficacy evaluation up to 12 weeks For those with a durable remission 12 weeks after infusion the follow-up will last for at least 12 months for disease control
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