Ignite Creation Date:
2024-05-06 @ 8:03 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237881
Status:
RECRUITING
Last Update Posted:
2024-05-02
First Post:
2024-01-25
Brief Title:
A Phase 12 Study of KSQ-001EX Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene in Patients With Select Advanced Solid Tumors
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase 12 Study of KSQ-001EX Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene in Patients With Select Advanced Solid Tumors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
To learn if KSQ-001EX is safe to give to participants with advanced forms of solid tumors
Detailed Description:
Phase I Primary Objectives To evaluate the safety and tolerability of KSQ-001EX in adult participants with advanced solid tumors melanoma HNSCC NSCLC
Phase I Primary Endpoint
Incidence of dose-limiting toxicities DLTs
Phase I Secondary Objectives
Determine expansion dose
Assess the safety and tolerability of KSQ-001EX in participants with advanced solid tumors melanoma HNSCC NSCLC
Evaluate preliminary antitumor activity of KSQ-001EX in participants with advanced solid tumors
Evaluate the feasibility of the manufacturing process
Phase I Secondary Endpoints
Incidence and severity of treatment-emergent adverse events TEAEs and change from Baseline in laboratory results
Objective response rate ORR duration of response DOR time to response TTR as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors RECIST v11
Manufacturing success rate
Phase 2 Primary Objectives To assess the anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors
Phase 2 Primary Endpoint
ORR per RECIST v11
Phase 2 Secondary Objectives
Assess the safety and tolerability of KSQ-001EX in patients with advanced solid tumors melanoma HNSCC NSCLC
Evaluate anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors
Evaluate overall survival OS
Evaluate the feasibility of the manufacturing process
Phase 2 Secondary Endpoints
Incidence and severity of TEAEs and change from Baseline in laboratory results
Complete response rate CRR DOR TTR progression-free survival PFS per RECIST v11
OS
Manufacturing success rate
Phase 12 Exploratory Objectives
Determine persistence of KSQ-001EX
Assess changes in immune and pharmacodynamic markers following KSQ-001EX infusion
Assess correlations of KSQ-001EX biomarkers and KSQ-001EX DP characteristics with safety clinical activity and KSQ-001EX persistence
Phase 12 Exploratory Endpoints
KSQ-001EX levels in blood and tumor tissue
Change from Baseline in soluble immune factors lymphocytes and immune markers
KSQ-001EX pharmacodynamic markers KSQ-001EX DP release criteria and KSQ-001EX persistence
Phase I Primary Endpoint
Incidence of dose-limiting toxicities DLTs
Phase I Secondary Objectives
Determine expansion dose
Assess the safety and tolerability of KSQ-001EX in participants with advanced solid tumors melanoma HNSCC NSCLC
Evaluate preliminary antitumor activity of KSQ-001EX in participants with advanced solid tumors
Evaluate the feasibility of the manufacturing process
Phase I Secondary Endpoints
Incidence and severity of treatment-emergent adverse events TEAEs and change from Baseline in laboratory results
Objective response rate ORR duration of response DOR time to response TTR as assessed by the Investigator per Response Evaluation Criteria in Solid Tumors RECIST v11
Manufacturing success rate
Phase 2 Primary Objectives To assess the anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors
Phase 2 Primary Endpoint
ORR per RECIST v11
Phase 2 Secondary Objectives
Assess the safety and tolerability of KSQ-001EX in patients with advanced solid tumors melanoma HNSCC NSCLC
Evaluate anti-tumor activity of KSQ-001EX in patients with advanced malignant solid tumors
Evaluate overall survival OS
Evaluate the feasibility of the manufacturing process
Phase 2 Secondary Endpoints
Incidence and severity of TEAEs and change from Baseline in laboratory results
Complete response rate CRR DOR TTR progression-free survival PFS per RECIST v11
OS
Manufacturing success rate
Phase 12 Exploratory Objectives
Determine persistence of KSQ-001EX
Assess changes in immune and pharmacodynamic markers following KSQ-001EX infusion
Assess correlations of KSQ-001EX biomarkers and KSQ-001EX DP characteristics with safety clinical activity and KSQ-001EX persistence
Phase 12 Exploratory Endpoints
KSQ-001EX levels in blood and tumor tissue
Change from Baseline in soluble immune factors lymphocytes and immune markers
KSQ-001EX pharmacodynamic markers KSQ-001EX DP release criteria and KSQ-001EX persistence
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-00734 | OTHER | NCI-CTRP Clinical Registry | None |