Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614686
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
U87 CAR-T in Patients With Advanced Head and Neck Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-arm Open-label Clinical Study to Evaluate the Safety Tolerability and Efficacy of U87 in Patients With Advanced Malignant Head and Neck Tumors
Status:
RECRUITING
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:
This is a single-arm open-label clinical study to evaluate the safety tolerability and efficacy of U87 injection solution in patients with advanced malignant head and neck tumors
Detailed Description:
Following consent patients must have tumor tissue evaluated by IHC assay Patients meeting all eligibility criteria will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of investigational drug product U87 Following manufacture of the drug product subjects will receive preconditioning prior to U87 infusion All subjects will be asked to continue to undergo long-term gene safety follow-up
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None