Ignite Creation Date:
2024-10-25 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06617572
Status:
AVAILABLE
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Expanded Access Protocol EAP for Nonconforming NC Afami-cel
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Expanded Access Protocol for Product Which Does Not Conform to the TECELRA Afamitresgene Autoleucel Suspension for Intravenous Infusion Commercial Release Specification
Status:
AVAILABLE
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this expanded access protocol EAP is to provide controlled access to Afamitresgene autoleucel suspension for intravenous infusion that does not meet the commercial release specification NC afami-cel This EAP will be conducted at authorized treatment centers where TECELRA is being administered and where the EAP is approved to be conducted Patients who are prescribed TECELRA sign the informed consent form and meet all entry criteria will be eligible to participate in this protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: