Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566092
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-17
Brief Title:
Study of Autologous Tumor-Infiltrating Lymphocytes in Pediatric Adolescent and Young Adult Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Multicenter Open-label 2-stage Single-arm Study to Evaluate the Safety and Tolerability of an Autologous Tumor-infiltrating Lymphocytes TIL Regimen and Preliminary Antitumor Activity of TIL in Pediatric Adolescent and Young Adult Participants With Relapsed or Refractory Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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 study is planned to test the safety and tolerability of the TIL regimen The study will also test how well TIL fights cancer The study will enroll children teenagers and young adults with solid tumors that have returned or are not responding to treatment for whom no effective standard-of-care treatment options exist
Study details include
The study will last up to 2 years after the TIL infusion Day 0 for each person
The treatment will last up to 10 days for each person
Study visits will be every 2 weeks until Day 42 every 6 weeks until Month 6 and every 3 months until Year 2
Study details include
The study will last up to 2 years after the TIL infusion Day 0 for each person
The treatment will last up to 10 days for each person
Study visits will be every 2 weeks until Day 42 every 6 weeks until Month 6 and every 3 months until Year 2
Detailed Description:
None
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