RecruitingPhase 1Phase 2NCT05588453

Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain

A Phase I/II Study of Ex-Vivo Expanded Allogeneic Universal Donor (UD) TGFbi NK Cell Infusions in Combination With Temozolomide as a Lymphodepleting Agent in Patients With Melanoma Metastatic to the Brain

Sponsor

Kari Kendra

Enrollment

30 participants

Start Date

Mar 1, 2023

Study Type

INTERVENTIONAL

Conditions

Clinical Stage IV Cutaneous Melanoma AJCC v8 Metastatic Melanoma Pathologic Stage IV Cutaneous Melanoma AJCC v8 Metastatic Malignant Neoplasm in the Brain

Summary

This phase I/II trial tests the safety, side effects, and best dose of universal donor UD TGFbetai natural killer (NK) cells, and whether UD TGFbetai NK cells with temozolomide works to shrink tumors in patients with stage IV melanoma that has spread to the brain (metastatic to the brain). NK cells are immune cells that contribute to anti-tumor immunity by recognizing and destroying transformed or stressed cells. Temozolomide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in the body. Giving UD TGFbetai NK cell and temozolomide may work better in treating patients with stage IV melanoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a treatment called NK cell therapy (using modified immune cells from a donor) combined with a chemotherapy drug called temozolomide for people with stage IV melanoma that has spread to the brain. The goal is to find out if this approach can safely shrink or control brain tumors. **You may be eligible if...** - You have stage IV melanoma that has spread to the brain, with at least one brain tumor that can be measured on MRI - Your brain tumor(s) have clearly grown or worsened - You have not had cancer treatment for at least 4 weeks - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are currently receiving other cancer treatments or radiation - You are taking high-dose steroids (above 4 mg/day) for brain swelling - You have a known reason you cannot have an MRI Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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