NCT06237881

A Phase 1/2 Study of KSQ-001EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate the SOCS1 Gene, in Patients With Select Advanced Solid Tumors

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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) v1.1 * 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 v1.1 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 v1.1 * OS * Manufacturing success rate Phase 1/2 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 1/2 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

Conditions

• Advanced Solid Tumor
• Melanoma
• Lung Neoplasms
• Head and Neck Neoplasms

Interventions

Type	Name	Description
DRUG	KSQ-001EX	Given by IV
DRUG	Interleukin-2	Given by IV
DRUG	Cyclophosphamide	Given by IV
DRUG	Fludarabine	Given by IV

Timeline

• Start date: 2024-01-31
• Primary completion: 2027-01-01
• Completion: 2029-01-01
• First posted: 2024-02-02
• Last updated: 2026-02-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study