Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2026-01-04 @ 1:35 AM
Study NCT ID:
NCT03275493
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2017-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Cells With CRS Suppression Technology for r/r CD19+ Acute Lymphoblastic Leukemia
Sponsor:
Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
Organization:
Study Overview
Official Title:
Chimeric Antigen Receptor T Cells Against CD19 With Cytokine Release Syndrome (CRS) Suppression Technology for Refractory/Relapsed CD19+ Acute Lymphoblastic Leukemia
Status:
RECRUITING
Status Verified Date:
2023-11
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,randomized ,two-cohorts, open-label ,phase 1/2 study to evaluate the efficacy and safety of T cells expressing CD19 chimeric antigen receptors treatment for relapsed/refractory CD19+ acute lymphoblastic leukemia patients.
Detailed Description:
Relapsed/refractory CD19 + acute lymphoblastic leukemia patients were randomly enrolled in this study to compare the efficacy and safety between two cohorts: 1. CD19 CAR-T cells； 2. CD19 CAR-T cells with CRS suppression technology.
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?: