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

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

Trial Details

NCT ID
NCT05588453
Phase
PHASE1 / PHASE2
Sponsor
Kari Kendra
Status
RECRUITING
Cancer Type
Melanoma
Interventions
  • Natural Killer Cell Therapy
  • Temozolomide
Locations (sample)
  • Columbus, Ohio, United States|39.96118,-82.99879

Key Eligibility Criteria

  • Histologically confirmed melanoma with stage IV disease
  • Radiologically confirmed brain metastasis (n \>= 1) with at least one measurable central nervous system (CNS) lesion \>= 10 mm on T1-weighted gadol…
  • No indication for stereotactic radiotherapy
  • At least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)

For full eligibility, visit ClinicalTrials.gov.

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