Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-29 @ 10:41 PM
Study NCT ID:
NCT05105867
Status:
UNKNOWN
Last Update Posted:
2023-05-10
First Post:
2021-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies
Sponsor:
920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Organization:
Study Overview
Official Title:
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma
Status:
UNKNOWN
Status Verified Date:
2023-04
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:
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.
Detailed Description:
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.
Study Oversight
Has Oversight DMC:
False
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?: