Ignite Creation Date:
2024-05-06 @ 6:20 PM
Last Modification Date:
2024-10-26 @ 2:46 PM
Study NCT ID:
NCT05628883
Status:
RECRUITING
Last Update Posted:
2024-07-10
First Post:
2022-11-14
Brief Title:
Proof of Concept of TBio-4101 Lymphodepleting Chemo IL-2 for RelapsedRefractory Melanoma
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Proof of Concept Study of TBio-4101 an Autologous Selected and Expanded Tumor Infiltrating Lymphocyte TIL Therapy Using Short-Term Cultured Selected Autologous TIL Following a Lymphodepleting Chemotherapy Regimen and Followed by IL-2 for Patients With Relapsed or Refractory Melanoma Phase 1
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:
The purpose of this first in human study is to evaluate the feasibility safety and efficacy of administering TBio-4101 tumor infiltrating lymphocytes TIL after receiving a lymphodepleting chemotherapy regimen and before receiving interleukin-2 IL-2 in participants with unresectable or metastatic melanoma
Detailed Description:
None
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