Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT01586403
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-10-30
First Post:
2012-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transfer of Genetically Engineered Lymphocytes in Melanoma Patients
Sponsor:
Loyola University
Organization:
Study Overview
Official Title:
Transfer of Genetically Engineered Lymphocytes in Melanoma Patients: A Phase 1 Dose Escalation Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2020-10
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 is a phase one trial to determine if genetically engineered lymphocytes can be safely delivered to patients with metastatic melanoma.
Detailed Description:
The goal of this study is to establish the recommended phase two dose of autologous T cell receptor transduced T cells when administered with low dose IL-2 to stage IV melanoma patients following a non-myeloablative and lymphodepleting chemotherapy preparative regimen. A secondary objective is to evaluate biologic and immunologic parameters associated with the adoptively transferred T cell receptor transduced T cells, including auditory and visual changes. The investigators believe the infusion of T cell receptor gene modified autologous T cells can mediate objective clinical responses in stage IV melanoma patients.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R44CA126461 | NIH | None | https://reporter.nih.gov/quic… | View |
| P01CA154778 | NIH | None | https://reporter.nih.gov/quic… | View |