Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508842
Status:
TERMINATED
Last Update Posted:
2022-09-28
First Post:
2020-08-09
Brief Title:
CD19CD22-Dual-STAR-T for Patients With B Cell Acute LeukemiaB-ALL
Sponsor:
Hebei Yanda Ludaopei Hospital
Organization:
Hebei Yanda Ludaopei Hospital
Study Overview
Official Title:
The Phase I Efficacy and Safety Clinical Study of CD19CD22-Dual-STAR-T Cells in Relapsed and Refractory B-ALL
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adjustment plan
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 CD19CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia
Detailed Description:
Patients with B cell acute leukemia will be enrolled and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5 -4 and -3 followed by infusion of Dual-STAR-T cellsDual-STAR-T cells will be intravenously infused with a escalated dose of 6E51E62E63E6 cellskgThe purpose of current study is to evaluate the clinical safety and efficacy of CD19CD22-Dual-STAR-T cells therapy in patients with refractory and relapsed B-ALLSafety and efficacy of Dual-STAR-T cells therapy will be monitored The primary endpoint is the safety of Dual-STAR-T cells including the effect ratio of CRS and ICANS ORR The secondary endpoint is the Dual-STAR-T cell proliferation ratio and Dual-STAR gene copied number in peripheral bloodPB and progression free survivalPFS overall-survivalOS and duration of overall responseDOR
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