Ignite Creation Date:
2024-05-06 @ 7:44 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06116110
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2023-10-30
Brief Title:
Lentiviral Gene Therapy Zamtocabtagene Autoleucel LTFU
Sponsor:
Miltenyi Biomedicine GmbH
Organization:
Miltenyi Biomedicine GmbH
Study Overview
Official Title:
A Prospective Observational Long-term Follow-up Study for Subjects Who Previously Received Zamtocabtagene Autoleucel in a United States Miltenyi Biomedicine-Sponsored Clinical Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 observational long-term follow-up LTFU study for subjects who previously received zamtocabtagene autoleucel known as MB-CART20191
Detailed Description:
This is a non-therapeutic study design After successful screening subjects will be monitored for potential gene therapy-related adverse events for up to 15 years post MB-CART20191 infusion Subjects will be assessed yearly for the occurrence of delayed adverse events AEs monitored for replication competent lentivirus RCL and assessed for long term efficacy as well as CAR-T persistence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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