NCT07028008

Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors

Clinical Study to Evaluate the Safety and Efficacy of Autologous Tumor-infiltrating Lymphocyte (CT-SP) in Patients With Refractory Melanoma Who Failed to Immune Checkpoint Inhibitors

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

For cancer patients who have failed conventional chemotherapy or are inoperable, targeted therapies-which block specific proteins involved in tumor growth-and immunotherapies-which activate T cells around the tumor to induce tumor cell death-have emerged as powerful treatment options. These therapies often result in longer survival with fewer side effects compared to traditional chemotherapy. However, a significant proportion of patients do not respond to either targeted therapies or immunotherapies, and treatment options for these individuals remain extremely limited. One of the most notable immunotherapies, immune checkpoint inhibitors, works by blocking immune checkpoint proteins (such as PD-1 and CTLA-4) to activate T cells within the tumor microenvironment, thereby enabling them to attack cancer cells. This approach has demonstrated remarkable efficacy in various solid tumors, including melanoma. Nonetheless, for many patients with immunologically "cold" tumors characterized by low infiltration of T cells, these therapies show low objective response rates, indicating the need for more proactive treatment strategies. In this study, we aim to administer the tumor-infiltrating lymphocyte (TIL) therapy CT-SP to patients with refractory melanoma, primarily to assess safety, and further to evaluate its anti-tumor efficacy by examining improvements in objective response rate (ORR) and progression-free survival (PFS). If this advanced regenerative clinical study demonstrates that CT-SP is both safe and effective, it could offer a powerful new treatment option for patients with refractory melanoma in Korea.

Conditions

• Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	tumor-infiltrating lymphocyte (TIL)	tumor-infiltrating lymphocyte (TIL): CT-SP 1\~100 x10 9 cells

Timeline

• Start date: 2025-10-15
• Primary completion: 2027-05-28
• Completion: 2029-05-28
• First posted: 2025-06-19
• Last updated: 2025-06-26