Ignite Creation Date:
2025-12-18 @ 9:50 AM
Ignite Modification Date:
2025-12-23 @ 9:56 PM
Study NCT ID:
NCT02529813
Status:
None
Last Update Posted:
2022-06-30 00:00:00
First Post:
2015-08-18 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19-Specific T-cells in Treating Patients With Advanced Lymphoid Malignancies
Sponsor:
None
Organization:
Study Overview
Official Title:
CD19+ Chimeric Antigen Receptor T Cells for Patients With Advanced Lymphoid Malignancies
Status:
None
Status Verified Date:
2022-06
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:
PRIMARY OBJECTIVES:
I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies.
SECONDARY OBJECTIVES:
I. To screen for the development of host immune responses against the CD19-specific chimeric antigen receptor (CAR).
II. To describe the homing ability of the infused T cells. III. To assess disease response. IV. To determine persistence of CAR+ T cells.
OUTLINE: This is a dose escalation study of CD19 positive chimeric antigen receptor T-cells.
LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate intravenously (IV) over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician.
Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1.
After completion of study treatment, patients are followed up for at least 15 years.
I. To determine the safety and maximum tolerated dose of genetically modified, CD19-specific T cells administered into patients with CD19+ advanced lymphoid malignancies.
SECONDARY OBJECTIVES:
I. To screen for the development of host immune responses against the CD19-specific chimeric antigen receptor (CAR).
II. To describe the homing ability of the infused T cells. III. To assess disease response. IV. To determine persistence of CAR+ T cells.
OUTLINE: This is a dose escalation study of CD19 positive chimeric antigen receptor T-cells.
LYMPHODEPLETING CHEMOTHERAPY: Patients may receive standard chemotherapy comprised of fludarabine phosphate intravenously (IV) over 1 hour and cyclophosphamide IV over 3 hours on days -5 to -3 or cyclophosphamide IV every 12 hours on days -5 to -3 at the discretion of the treating physician.
Within 30 days post completion of lymphodepletion, patients receive CD19 positive chimeric antigen receptor T-cells IV over 15-30 minutes on day 0, or split into two portions on days 0 and 1.
After completion of study treatment, patients are followed up for at least 15 years.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: