Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04429438
Status:
UNKNOWN
Last Update Posted:
2020-06-12
First Post:
2020-06-09
Brief Title:
Multi-CAR-T Cells Targeting B Cell Lymphomas
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
Primary Booster and Consolidation Multi-CAR-T Cell Therapy for the Treatment of Refractory B Cell Lymphomas
Status:
UNKNOWN
Status Verified Date:
2020-06
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:
This study aims to evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting B cell surface molecules including CD19 and alternative CARTs as booster and consolidation treatment for patients with highly resistant B cell lymphomas including primary mediastinal B cell lymphoma PMBCL and BCL involving central nervous system CNS-BCL Clinical response and development of a simplified and standardized lentiviral vector and cell production protocol will be investigated This is a phase III trial enrolling patients from multiple clinical centers
Detailed Description:
Chimeric antigen receptor CAR T cell therapy has proven effective in treating B cell malignancies However post CD19-CART relapses occur at high rate due to the CD19 antigen loss or the exhaustion of CART cells Furthermore the success of treating relapsedrefractory B cell lymphoma BCL such as primary mediastinal B-cell lymphoma PMBCL and CNS-involved BCL has been limited To overcome tumor escape and prolong in vivo CART efficacy we have developed a novel multiple CAR-T therapy regimen including booster and consolidation CART applications to to target highly-refractory cancer Selected patients will be enrolled after target antigen confirmation including CD19 CD20 CD22 CD70 CD13 CD79b GD2 and PSMA through immunostaining of their tumor specimens The aim is to evaluate safety and long term efficacy of the multiple CART therapy strategy in the BCL patients
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