OncoMatch/Clinical Trials/NCT05588453
Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
Is NCT05588453 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Natural Killer Cell Therapy and Temozolomide for clinical stage iv cutaneous melanoma ajcc v8.
Treatment: Natural Killer Cell Therapy · Temozolomide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Melanoma
Tumor Agnostic
Disease stage
Required: Stage IV
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic treatment or radiation therapy
Exception: at least 4 weeks from any anticancer treatment (cytotoxic chemotherapy, signal transduction inhibitors, immunotherapy or radiation)
Planned or concurrent systemic treatment or radiation therapy
Cannot have received: investigational drugs
Patients who received any other investigational drugs within the 30 days prior to screening visit
Lab requirements
Blood counts
ANC 1 x 10^9/L; Platelets > 100,000/L; Hgb >= 10 g/dL
Kidney function
Creatinine <= 1.5 x ULN
Liver function
AST and ALT < 5 x ULN if documented liver metastases or < 3 X ULN without liver metastasis; Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome; Albumin >= 2.5 g/dL
ANC 1 x 10^9/L; Platelets > 100,000/L; Hgb >= 10 g/dL; Creatinine <= 1.5 x ULN; Albumin >= 2.5 g/dL; Serum bilirubin < 1.5 x ULN unless due to Gilbert's syndrome; AST and ALT < 5 x ULN if documented liver metastases or < 3 X ULN without liver metastasis
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Ohio State University Comprehensive Cancer Center · Columbus, Ohio
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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