Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04888468
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2021-05-12
Brief Title:
Phase I Study of pCAR-19B in the Treatment of CD19-positive RelapsedRefractory B-ALL in Children and Adolescents
Sponsor:
Chongqing Precision Biotech Co Ltd
Organization:
Chongqing Precision Biotech Co Ltd
Study Overview
Official Title:
A Phase I Clinical Study of Anti-CD19 CAR-T Therapy pCAR-19B in the Treatment of CD19-positive RelapsedRefractory B-ALL
Status:
COMPLETED
Status Verified Date:
2021-05
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 phase I clinical study to evaluate the safety and tolerability of pCAR-19B in patients with relapsed or refractory B-ALL and to obtain the maximum tolerated dose of pCAR-19B and phase II Recommended dose
Detailed Description:
This is a single-center single-arm open-label study The study plans to set up 3 dose groups adopting a dose-escalating 33 design and plan to recruit about 9-18 subjects with relapsed or refractory B-ALLpCAR-19B will be infused to the subject by intravenous infusion
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