Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04732845
Status:
RECRUITING
Last Update Posted:
2023-08-29
First Post:
2021-01-27
Brief Title:
Human AntiCD19 Chimeric Antigen Receptor T Cells for Relapsed or Refractory Lymphoid Malignancies
Sponsor:
Benjamin Tomlinson
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Clinical Trial of Human AntiCD19 Chimeric Antigen Receptor T Cells for Treatment of Relapsed or Refractory Lymphoid Malignancies Non-Hodgkin Lymphoma Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia
Status:
RECRUITING
Status Verified Date:
2024-09
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 relapsed or refractory lymphoid malignancies Non-Hodgkin Lymphoma Acute Lymphoblastic Leukemia Chronic Lymphocytic Leukemia with a new type of T cell-based immunotherapy therapy that uses the immune system to treat the cancer
Detailed Description:
This study seeks to determine the safety of the treatment of relapsed or refractory B cell lymphomas relapsed refractory chronic lymphocytic leukemia and relapsedrefractory acute lymphoblastic leukemia with chimeric antigen receptor T cells targeting CD19 and to find the recommended phase II dose for this cellular therapy
T cells are a type of white blood cell that helps the body fight infections This treatment uses T cells already present within the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer Lentivirus is a family of viruses that can be used by scientists to alter cells which then could be used to change the course of a disease 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 human chimeric antigen receptor T cells CAR-T cells The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active The CAR-T cells will be returned to the body through an intravenous IV infusion Another purpose of this study is to learn about the side effects and toxicities related to this treatment Human CAR-T cell therapy is investigational experimental and works by removing T cells from the blood and modifying them to be able to target 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 the body that have been modified outside of the body by a lentivirus and then returned to the participant by an infusion to target the cancer Lentivirus is a family of viruses that can be used by scientists to alter cells which then could be used to change the course of a disease 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 human chimeric antigen receptor T cells CAR-T cells The CAR-T cells that will be reinfused to the body are modified using a lentivirus that is no longer active The CAR-T cells will be returned to the body through an intravenous IV infusion Another purpose of this study is to learn about the side effects and toxicities related to this treatment Human CAR-T cell therapy is investigational experimental and works by removing T cells from the blood and modifying them to be able to target the cancer
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None