Ignite Creation Date:
2024-05-06 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03559439
Status:
UNKNOWN
Last Update Posted:
2020-11-05
First Post:
2018-05-30
Brief Title:
CD19-targeting CAR T Cells in Relapsed or Refractory CD19 Positive B-cell Malignancies
Sponsor:
Shanghai Tong Ren Hospital
Organization:
Shanghai Tong Ren Hospital
Study Overview
Official Title:
CD19-targeting CAR T Cell Therapy in the Treatment of Relapsed or Refractory CD19 Positive B-cell Malignancies
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
This is a single center single arm open-label phase 1 study to determine the safety and efficacy of autologous T cells expressing CD19 chimeric antigen receptors in adults with CD19 B cell malignancies
Detailed Description:
This is a single-center Open Label phase I clinical trial 9 subjects planned to be enrolled The subjects will be divided into low-dose group medium-dose group and high-dose groupDose CAR cellskg Low 1105 Medium 2106 High 6106
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