Ignite Creation Date:
2024-05-06 @ 1:10 PM
Last Modification Date:
2024-10-26 @ 1:10 PM
Study NCT ID:
NCT03953599
Status:
COMPLETED
Last Update Posted:
2022-02-01
First Post:
2019-05-15
Brief Title:
CD19-Synthetic T Cell Antigen ReceptorSTAR-T in B-cell Malignancies Patients
Sponsor:
Hebei Yanda Ludaopei Hospital
Organization:
Hebei Yanda Ludaopei Hospital
Study Overview
Official Title:
CD19-STAR-T for Patients With B Cell Malignancies
Status:
COMPLETED
Status Verified Date:
2021-08
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:
None
Brief Summary:
This is a single center single arm open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies such as NHL and ALL
Detailed Description:
This Phase I study is designed as a pilot trial evaluating the safety and of CD19-STAR-T cell therapy in subjects with refractory and relapsed B cell malignancies Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5 -4 and -3 followed by infusion of CD19-STAR-T cells Safety and efficacy of CD19-STAR-T cells therapy will be monitored The purpose of current study is to determine the clinical efficacy and safety of CD19-STAR-T cells therapy in patients with refractory and relapsed B-cell malignancies
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