Ignite Creation Date:
2024-05-06 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06213636
Status:
RECRUITING
Last Update Posted:
2024-04-09
First Post:
2024-01-10
Brief Title:
Fourth-gen CAR T Cells Targeting CD19CD22 for Highly Resistant B-cell LymphomaLeukemia PMBCLCNS-BCL
Sponsor:
Essen Biotech
Organization:
Essen Biotech
Study Overview
Official Title:
T-cell Infusion Targeting CD19 and CD22 for RefractoryRelapsed LeukemiaLymphoma Patients With or Without Central Nervous System Involvement
Status:
RECRUITING
Status Verified Date:
2024-08
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:
BAH241
Brief Summary:
This is an open-label single-arm phase I clinical trial with dose escalation designed to investigate the safety tolerability and pharmacokinetic properties of Human CD19-CD22 Targeted T Cells Infusion The primary objectives are to preliminarily assess the impact of Human CD19-CD22 Targeted T Cells Infusion in patients with relapsedrefractory B-cell acute lymphoblastic leukemia and to explore the appropriate dose and reinfusion schedule for phase II
Eligible participants including those with Central Nervous System Lymphoma B Cell Lymphoma BCL Acute Lymphocytic Leukemia ALL Acute Lymphoblastic Leukemia ALL B Acute Lymphoblastic Leukemia B-ALL Refractory Non-Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia CLL Refractory B Acute Lymphoblastic Leukemia B-ALL Diffuse Large B Cell Lymphoma Lymphoid Leukemia and MRD-positive cases can participate Eligibility will be determined through a comprehensive assessment including disease evaluations a physical examination Electrocardiograph Computed Tomography CT Magnetic Resonance Imaging MRI Positron Emission Tomography PET and blood tests Prior to the infusion of CD19-CD22 CAR T cells participants will undergo chemotherapy After the infusion participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR T cells Certain study procedures may be conducted during hospitalization
Eligible participants including those with Central Nervous System Lymphoma B Cell Lymphoma BCL Acute Lymphocytic Leukemia ALL Acute Lymphoblastic Leukemia ALL B Acute Lymphoblastic Leukemia B-ALL Refractory Non-Hodgkin Lymphoma Refractory Chronic Lymphocytic Leukemia CLL Refractory B Acute Lymphoblastic Leukemia B-ALL Diffuse Large B Cell Lymphoma Lymphoid Leukemia and MRD-positive cases can participate Eligibility will be determined through a comprehensive assessment including disease evaluations a physical examination Electrocardiograph Computed Tomography CT Magnetic Resonance Imaging MRI Positron Emission Tomography PET and blood tests Prior to the infusion of CD19-CD22 CAR T cells participants will undergo chemotherapy After the infusion participants will be closely monitored for potential side effects and the effectiveness of CD19-CD22 CAR T cells Certain study procedures may be conducted during hospitalization
Detailed Description:
This clinical trial involves the use of Chimeric Antigen Receptor T-cell CAR-T therapy targeting CD19 and CD22 in patients with various hematologic malignancies including B-cell acute lymphoblastic leukemia B-ALL B-cell lymphomas refractory non-Hodgkin lymphoma chronic lymphocytic leukemia CLL diffuse large B-cell lymphoma DLBCL lymphoid leukemia and cases positive for minimal residual disease MRD CD19 and CD22 are cell surface molecules commonly found on B cells and their targeted therapy using CAR-T cells has shown promise in the treatment of these malignancies
Intervention
The intervention in this clinical trial involves the infusion of Human CD19-CD22 Targeted T Cells which have been genetically engineered to express chimeric antigen receptors specific to CD19 and CD22 These CAR-T cells are designed to recognize and bind to CD19 and CD22 molecules on the surface of malignant B cells leading to their destruction The infusion of CAR-T cells will be administered to eligible participants as part of their treatment regimen
Objectives
The primary objectives of this intervention are as follows
To evaluate the safety and tolerability of the CD19 and CD22 CAR-T cell therapy
To assess the pharmacokinetic characteristics of the infused CAR-T cells To preliminarily observe the clinical effectiveness of CD19 and CD22 CAR-T cell therapy in various hematologic malignancies including B-ALL B-cell lymphomas refractory non-Hodgkin lymphoma CLL DLBCL lymphoid leukemia and MRD-positive cases
To determine the clinically applicable dose and reinfusion regimen for phase II trials
Mechanism of Action
CD19 and CD22 are cell surface antigens commonly expressed on B-cell malignancies The CD19-CD22 CAR-T cells are engineered to express a chimeric antigen receptor composed of an extracellular domain that recognizes CD19 and CD22 a transmembrane domain and intracellular signaling domains When these modified T cells encounter B cells expressing CD19 and CD22 the CAR-T cells are activated leading to their binding to the malignant B cells This binding triggers a cytotoxic response resulting in the destruction of the target B cells
Treatment Regimen
Prior to the infusion of CD19-CD22 CAR-T cells participants will undergo preconditioning chemotherapy This chemotherapy serves to prepare the patients immune system for the CAR-T cell therapy Following chemotherapy participants will receive the infusion of CD19-CD22 CAR-T cells
Monitoring and Follow-up
After the CAR-T cell infusion participants will be closely monitored for side effects and adverse events Additionally the clinical response and effectiveness of CD19-CD22 CAR-T cells in controlling the malignancy will be assessed through various evaluations including disease assessments imaging studies CT MRI PET and blood tests These assessments may be performed while participants are hospitalized
Rationale
CD19 and CD22 are well-established targets for CAR-T cell therapy in B-cell malignancies By targeting both CD19 and CD22 this approach aims to maximize the therapeutic benefit and expand the applicability of CAR-T therapy to a broad spectrum of hematologic malignancies The rationale behind this clinical trial is to further evaluate the safety efficacy and optimal dosing regimens of CD19 and CD22 CAR-T cells in various patient populations with these malignancies Ultimately the goal is to provide a promising treatment option for patients with relapsedrefractory B-cell malignancies including those with central nervous system involvement who have limited therapeutic alternatives
Intervention
The intervention in this clinical trial involves the infusion of Human CD19-CD22 Targeted T Cells which have been genetically engineered to express chimeric antigen receptors specific to CD19 and CD22 These CAR-T cells are designed to recognize and bind to CD19 and CD22 molecules on the surface of malignant B cells leading to their destruction The infusion of CAR-T cells will be administered to eligible participants as part of their treatment regimen
Objectives
The primary objectives of this intervention are as follows
To evaluate the safety and tolerability of the CD19 and CD22 CAR-T cell therapy
To assess the pharmacokinetic characteristics of the infused CAR-T cells To preliminarily observe the clinical effectiveness of CD19 and CD22 CAR-T cell therapy in various hematologic malignancies including B-ALL B-cell lymphomas refractory non-Hodgkin lymphoma CLL DLBCL lymphoid leukemia and MRD-positive cases
To determine the clinically applicable dose and reinfusion regimen for phase II trials
Mechanism of Action
CD19 and CD22 are cell surface antigens commonly expressed on B-cell malignancies The CD19-CD22 CAR-T cells are engineered to express a chimeric antigen receptor composed of an extracellular domain that recognizes CD19 and CD22 a transmembrane domain and intracellular signaling domains When these modified T cells encounter B cells expressing CD19 and CD22 the CAR-T cells are activated leading to their binding to the malignant B cells This binding triggers a cytotoxic response resulting in the destruction of the target B cells
Treatment Regimen
Prior to the infusion of CD19-CD22 CAR-T cells participants will undergo preconditioning chemotherapy This chemotherapy serves to prepare the patients immune system for the CAR-T cell therapy Following chemotherapy participants will receive the infusion of CD19-CD22 CAR-T cells
Monitoring and Follow-up
After the CAR-T cell infusion participants will be closely monitored for side effects and adverse events Additionally the clinical response and effectiveness of CD19-CD22 CAR-T cells in controlling the malignancy will be assessed through various evaluations including disease assessments imaging studies CT MRI PET and blood tests These assessments may be performed while participants are hospitalized
Rationale
CD19 and CD22 are well-established targets for CAR-T cell therapy in B-cell malignancies By targeting both CD19 and CD22 this approach aims to maximize the therapeutic benefit and expand the applicability of CAR-T therapy to a broad spectrum of hematologic malignancies The rationale behind this clinical trial is to further evaluate the safety efficacy and optimal dosing regimens of CD19 and CD22 CAR-T cells in various patient populations with these malignancies Ultimately the goal is to provide a promising treatment option for patients with relapsedrefractory B-cell malignancies including those with central nervous system involvement who have limited therapeutic alternatives
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