NCT05588453

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

Recruiting now Phase 1, PHASE2 Last updated 12 January 2026

What this trial tests

Phase 1, PHASE2 trial testing Natural Killer Cell Therapy in Clinical Stage IV Cutaneous Melanoma AJCC v8 in 30 participants. Currently enrolling.

Timeline

1 March 2023

Primary endpoint
15 April 2026

15 April 2026

Quick facts

Lead sponsor	Kari Kendra
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 March 2023
Primary completion	15 April 2026
Estimated completion	15 April 2026
Sites	1 location across United States

Drugs / interventions tested

• Natural Killer Cell Therapy — full drug profile →
• Temozolomide (temozolomide) — full drug profile →

Conditions studied

• Clinical Stage IV Cutaneous Melanoma AJCC v8 — all drugs for Clinical Stage IV Cutaneous Melanoma AJCC v8 →
• Metastatic Malignant Neoplasm in the Brain — all drugs for Metastatic Malignant Neoplasm in the Brain →
• Metastatic Melanoma — all drugs for Metastatic Melanoma →
• Pathologic Stage IV Cutaneous Melanoma AJCC v8 — all drugs for Pathologic Stage IV Cutaneous Melanoma AJCC v8 →

Sponsor

Kari Kendra — full company profile →

Who can join

18 and older, any sex, with Clinical Stage IV Cutaneous Melanoma AJCC v8 or Metastatic Malignant Neoplasm in the Brain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Cell Immunotherapy against Melanoma: Clinical Trials Review.
   Filin IY, Mayasin YP, Kharisova CB, Gorodilova AV, et al · · 2023 · cited 16× · PMID 36768737 · DOI 10.3390/ijms24032413
2. The immune landscape in brain metastasis.
   Schreurs LD, Vom Stein AF, Jünger ST, Timmer M, et al · · 2025 · cited 15× · PMID 39403738 · DOI 10.1093/neuonc/noae219
3. Recent Advancements in Cell-Based Therapies in Melanoma.
   Nassief G, Anaeme A, Moussa K, Mansour AN, et al · · 2024 · cited 5× · PMID 39337333 · DOI 10.3390/ijms25189848
4. Prevention of Brain Metastases: A New Frontier.
   Pellerino A, Davidson TM, Bellur SS, Ahluwalia MS, et al · · 2024 · cited 4× · PMID 38893253 · DOI 10.3390/cancers16112134
5. Multiplexed iPSC platform for advanced NK cell immunotherapies.
   Kumar A, Fischer C, Cichocki F, Miller JS. · · 2025 · cited 3× · PMID 40780202 · DOI 10.1016/j.xcrm.2025.102282
6. Unraveling the Enigma of Melanoma Brain Metastasis: New Molecular Insights and Therapeutic Directions
   O’Toole K, Roan B, Hardman T, Phillips P, et al · · 2026
7. Melanoma treatment in the era of nanotechnology and precision medicine.
   da Cruz AF, Colella F, Grasso G, Onesto V, et al · · 2025 · PMID 41419864 · DOI 10.1186/s12951-025-03851-8
8. Cell therapies against brain tumors: Clinical development and emerging prospects.
   Fukuta T, Shaha S, da Silva-Candal A, Zhao Z, et al · · 2025 · PMID 41030289 · DOI 10.1002/btm2.70018