Ignite Creation Date:
2024-07-17 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06479356
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-24
Brief Title:
CD19-targeted CAR T Cells for Relapsed or Refractory RR Large B-cell Lymphoma
Sponsor:
Shanghai Ming Ju Biotechnology Co Ltd
Organization:
Shanghai Ming Ju Biotechnology Co Ltd
Study Overview
Official Title:
An Open-Label Single-Arm Study of Relma-cel CD19-targeted Chimeric Antigen Receptor CART Cells for Relapsed or Refractory RR LBCL
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:
None
Brief Summary:
This is an open-label single-arm study to treat the adult RR Large B-cell Lymphoma subjects with Relmacabtagene autoleucel relma-cel in China
Detailed Description:
This is an open-label single-arm study conducted in adult subjects with RR LBCL in China to evaluate efficacysafety and pharmacokineticsPK of relma-cel
Relma-cel was approved by the China National Medical Products AdministrationNMPAin September 2021Acceptance NoCXSS2000036for the treatment of adult patients with RR LBCL after second-line or more systemic therapyThe recommended dose is 1108 CART cellsThe indication for this application is RR LBCL and the recommended dose is 1108 CART cells
Relma-cel was approved by the China National Medical Products AdministrationNMPAin September 2021Acceptance NoCXSS2000036for the treatment of adult patients with RR LBCL after second-line or more systemic therapyThe recommended dose is 1108 CART cellsThe indication for this application is RR LBCL and the recommended dose is 1108 CART cells
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