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NCT05588453 · ClinicalTrials.gov registry record · Phase 1
Natural Killer Cell Therapy (UD TGFbetai NK Cells) and Temozolomide for the Treatment of Stage IV Melanoma Metastatic to the Brain
A Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by Kari Kendra.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT05588453: Recruiting Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, sponsored by Kari Kendra.
NCT05588453 is a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain that is actively recruiting participants, run by Kari Kendra. The registered enrollment target is 30 participants, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05588453, a Phase 1 study of Metastatic Melanoma and Metastatic Malignant Neoplasm in the Brain, is actively recruiting participants, sponsored by Kari Kendra.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Toxicity will be graded using the Common Terminology Criteria for Adverse Events (CTCAE) criteria, version 4.03. The CTCAE provides descriptive terminology and a grading scale for each adverse event listed. All toxicities will be summarized as the percentage of patients experiencing each type and grade of event according to dose level.
Conditions Studied
Interventions
- DRUG Temozolomide
- BIOLOGICAL Natural Killer Cell Therapy
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-03-01 |
| Est. Completion | 2026-04-15 |
| Phase | Phase 1 |
What NCT05588453 shows while recruiting
NCT05588453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 83-participant average among 91 other Metastatic Melanoma trials with a reported enrollment target (64% lower).
The record links to 4 conditions, with Metastatic Melanoma appearing as the primary indexed condition, and to 2 interventions - of which Temozolomide is the first listed.
NCT05588453 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05588453 about?
NCT05588453 is a clinical study titled "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 ...
What is the current status of trial NCT05588453?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2023-03-01. Estimated completion is 2026-04-15.
What conditions does trial NCT05588453 study?
This clinical trial studies the following conditions: Metastatic Melanoma, Metastatic Malignant Neoplasm in the Brain, Clinical Stage IV Cutaneous Melanoma AJCC v8, Pathologic Stage IV Cutaneous Melanoma AJCC v8.
What interventions are being tested in trial NCT05588453?
The interventions under investigation include: Temozolomide (DRUG), Natural Killer Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT05588453?
This trial is sponsored by Kari Kendra, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05588453 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05588453's enrollment target sits among peer trials
30 55th of 91 higher than 33 of 91 other Metastatic Melanoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Melanoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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