Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-01-02 @ 8:41 AM
Study NCT ID:
NCT06505551
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-17
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
Sponsor:
SCG Cell Therapy Pte. Ltd.
Organization:
Study Overview
Official Title:
A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
Detailed Description:
This study will be conducted in 2 parts:
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D.
The Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
Study Oversight
Has Oversight DMC:
True
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?: