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

Inclusion criteria

• . Unresectable, incurable and/or metastatic histologically and/or cytologically confirmed melanoma (Stage IIIC/IIID or Stage IV) that has progressed following at least 1 line of prior systemic therapy including treatment with anti-PD-1/PD-L1 inhibitor alone or in combination with anti-CTLA-4 inhibitor or anti-LAG-3 antibody. Note: Up to 5 mucosal melanoma patients can be treated in melanoma expansion cohort only.
• . Histologically and/or cytologically confirmed primary diagnosis of NSCLC which has progressed on standard therapy which includes treatment with platinum-based chemotherapy and checkpoint inhibitor therapy (either given in combination or sequentially)
• . Absolute neutrophil count (ANC) of ≥ 1 × 109/L
• . Platelet count of ≥ 100.0 × 109/L
• . Hemoglobin of ≥ 9.0 g/dL
• . Total bilirubin ≤ 2.0 × upper limit of normal (ULN) unless associated with Gilbert's syndrome
• . Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN (or ≤ 5 × ULN in patients with liver metastases)
• . Targeted therapy: prior targeted therapy with a BRAK/MEK, EGFR, ALK, receptor tyrosine kinase, or other-directed agent (eg, erlotinib, afatinib, osimertinib, crizotinib, ceritinib), is allowed provided the washout is a minimum of 21 days or 5 half-lives, whichever is longer prior to start of therapy (LDC)

Exclusion criteria