A Phase 1/2 Study of KSQ-004EX, Autologous Tumor Infiltrating Lymphocytes Engineered to Inactivate Genes Encoding SOCS1 and Regnase-1, in Patients With Select Advanced Solid Tumors
M.D. Anderson Cancer Center
Summary
Phase 1 is to find the recommended dose of KSQ-004EX to give to participants with advanced solid tumors. Phase 2 is to learn if KSQ-004EX at the recommended dose found in Phase1 can help to control advanced solid tumors. The safety and effects of KSQ-004EX will also be studied in both phases.
Description
Phase 1: Dose Escalation Primary Objective: * To evaluate the safety and tolerability of KSQ-004EX in adult participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) Secondary Objectives * Determine expansion dose * Assess the safety and tolerability of KSQ-004EX in participants with advanced solid tumors (melanoma, NSCLC, HNSCC, CRC, pancreatic cancer, and cervical cancer) * Evaluate preliminary anti-tumor activity of KSQ-004EX in participants with advanced solid tumors * Evaluate the feasibility of the manufacturing process Phase 2: Expa…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Diagnosed with one of the following tumor types: 1. Unresectable, incurable and/or metastatic histologically and/or cytologically confirmed cutaneous, acral, or unknown primary melanoma (Stage IIIC or Stage IV) that has progressed following at least 1 and no more than 3 lines of prior therapy in the advanced/metastatic setting, one of which includes treatment with anti-PD-1/PD-L1 inhibitor alone or in combination with anti-cytotoxic T lymphocyte associated protein 4 (anti-CTLA-4) inhibitor or in combination with anti-LAG-3 antibody. Note: Up to 5 mucosal pati…
Interventions
- DrugCyclophosphamide
Given by IV
- DrugFludarabine
Given by IV
- DrugKSQ-004EX
Given by IV
- DrugInterleukin-2
Given by IV
Location
- MD Anderson Cancer CenterHouston, Texas