Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04833504
Status:
COMPLETED
Last Update Posted:
2021-04-06
First Post:
2020-12-14
Brief Title:
Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
Sponsor:
Second Affiliated Hospital School of Medicine Zhejiang University
Organization:
Second Affiliated Hospital School of Medicine Zhejiang University
Study Overview
Official Title:
Clinical Follow-up Study of CD19 CAR-T Expressing IL7 and CCL19 for Relapsed or Refractory B Cell Lymphoma
Status:
COMPLETED
Status Verified Date:
2021-01
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 study is designed to monitor all patients exposed to CD19 CAR-T expressing IL7 and CCL19 for 5 years following infusion to assess their long-term efficacy including the CAR-vector persistence the normal immunity rebuilding and the risk of delayed adverse events AEs
Detailed Description:
Patients are enrolled following completion from the early clinical study of CD19-7X19 CAR-T treatment NCT03258047 and will be followed for 5 years post treatment from the last treatment They will be monitored for safety and efficacy with the primary treatment protocols for the protocol defined duration This long-term following up study allow an interim analysis to evaluate the outcomes of the study when it arrives in 2 years Collection of such long term effects of CAR-T cell therapy will help to further define the risk-benefit profile of CAR-T Therapies
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