Ignite Creation Date:
2024-07-17 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-06
Brief Title:
Long-term Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Sponsor:
Juventas Cell Therapy Ltd
Organization:
Juventas Cell Therapy Ltd
Study Overview
Official Title:
A Long Term Follow-up Observational Study of Patients Treated With Inaticabtagene Autoleucel Injection
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
This clinical trial adopts an observational research method to conduct annual follow-up and monitoring of patients receiving treatment with Inaticabtagene Autoleucel Injection after its commercialization in order to evaluate the delayed adverse events of Inaticabtagene Autoleucel Injection
Detailed Description:
Patients treated with Inaticabtagene Autoleucel Injection including registered clinical trial patients with different indications of this product and commercialized patients after market launch would be included in this program for a maximum of 15 years of long-term follow-up LTFU and an informed consent form must be signed again The research period was 15 years after Inaticabtagene Autoleucel infusion The patient was followed up once a year for 15 years
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