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

Sponsor
Samsung Medical Center
Study ID
NCT07028008
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • tumor-infiltrating lymphocyte (TIL) — BIOLOGICAL
    tumor-infiltrating lymphocyte (TIL): CT-SP 1\~100 x10 9 cells

Study Details

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.

Key Dates

First listed
Jun 19, 2025
Start date
Oct 15, 2025
Status verified
Jun 2025
Primary completion
May 28, 2027
Completion
May 28, 2029

Study Design

Enrollment
9 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: tumor-infiltrating lymphocyte (TIL) therapy
    1\~100 x 10 9 cells, 1time, IV

Primary Outcome Measure

Safety evaluation [ Time Frame: up to 6 months after TIL administration ]

Central Contacts

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