drugset / Trial / NCT05588453

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

NCT05588453

Phase 1/2 Recruiting 24 enrolled Kari Kendra
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2023-03-01
Primary completion
2027-04-15
Completion
2027-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Temozolomide Small molecule Oral
Subject Universal Donor Expanded TGF-beta-imprinted NK Cells Cell therapy Intravenous