Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06505551
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Phase 12 Study of Autologous SCG142 TCR T Cells in Patients With HPV1652-positive Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 12 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:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 12 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 andor 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:
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