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 (NCT06237881)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Diagnosed with one of the following tumor types:
2. 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.
3. 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) i. Participants with tumors that have known actionable molecular alteration such as EGFR, ALK, ROS-1, BRAF, RET, MET and KRAS must have progressed on standard directed molecular therapy in addition to platinum-based chemotherapy. c. Locally advanced, recurrent and/or metastatic histologically and/or cytologically confirmed HNSCC that has been previously treated with at least 1 and no more than 3 lines of prior therapy i. Participants must have received a platinum-containing chemotherapy regimen for the treatment of primary tumor in locally advanced, or metastatic setting. ii. Participants must have received an anti-PD-1/PD-L1 as monotherapy or in combination with chemotherapy • Resectable lesion(s) for KSQ-001EX manufacturing (tumor ≥1.5cm2 or at least 5 core biopsies)
4. At least 1 measurable lesion per RECIST v1.1 (Eisenhauer 2009) following tumor resection for KSQ-001EX manufacturing Note: Lesions in previously irradiated areas should not be selected as a target lesion unless radiation treatment was ≥ 3 months prior, and there has been demonstrated disease progression in the lesion
5. Age: between 18 - 70 years old
6. Life expectancy of ≥ 12 weeks
7. Recovered to ≤ Grade 1 or Baseline toxicity (except alopecia, neuropathy, and endocrinopathies from prior immunotherapy) from prior therapy (per CTCAE)
8. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
9. Adequate bone marrow function defined as:
10. Absolute neutrophil count (ANC) of ≥ 1 × 109/L
11. Platelet count of ≥ 100.0 × 109/L
12. Hemoglobin of ≥ 9.0 g/dL

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

• MD Anderson Cancer Center — Houston, Texas

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.