Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT03434769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-06
First Post:
2018-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Non Hodgkin Lymphoma
Sponsor:
Benjamin Tomlinson
Organization:
Study Overview
Official Title:
Phase I Clinical Trial of AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Non Hodgkin Lymphoma
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-12
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:
The purpose of this study is to determine if it is possible to treat your cancer with a new type of T cell-based immunotherapy (therapy that uses your immune system to treat the cancer). T cells are a type of white blood cell that helps the body fight infections. This treatment uses T cells already present within your body that have been modified outside of the body and returned to target your cancer. This type of treatment is sometimes referred to as adoptive cell transfer (ACT). In this study the specific type of cells that will be used is called chimeric antigen receptor T cells (CAR T cells). Another purpose of this study is to learn about the side effects and toxicities related to this treatment.
Detailed Description:
Primary Objective: To determine the safety of the treatment of relapsed or refractory B cell lymphomas with chimeric antigen receptor T cells targeting cluster of differentiation antigen 19 (CD19) and to find the recommended phase II dose for this cellular therapy
Secondary Objectives
* To describe the safety profile of the infusion of CAR-T cells targeting CD19.
* To describe the toxicities related to infusion of CAR-T cells targeting CD19.
* To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19.
Secondary Objectives
* To describe the safety profile of the infusion of CAR-T cells targeting CD19.
* To describe the toxicities related to infusion of CAR-T cells targeting CD19.
* To describe the overall response rate and complete response rate of relapsed B cell malignancies treated with CAR-T cells targeting CD19.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: