PRAME-TCR-NK Cells for Recurrent/Refractory Melanoma
This study is testing a new treatment called PRAME-TCR-NK cells for people with melanoma that has come back or not responded to previous treatments. Researchers want to find the safest and most effective dose of these cells. You would also receive two other drugs, Cyclophosphamide and Fludarabine, given through an IV. To join, you must be 18 or older, have a specific genetic marker called HLA A*02:01, and have melanoma that has not responded to immune checkpoint inhibitor therapy. The main goal is to understand the safety and side effects of the PRAME-TCR-NK cells. This study aims to enroll 39 participants.
- Study design
- This is a Phase 1 interventional study, meaning it's an early-stage trial to find a safe dose. It plans to enroll 39 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and side effects will be measured through study completion, which is an average of 1 year.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1 Dose Escalation and Expansion Study of PRAME T Cell Receptor (TCR) Engineered NK Cells in Participants With Recurrent and/or Refractory Melanoma (PRAMETIME-Mel)
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Isabella C Glitza Oliva, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Safety and adverse events (AEs)Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0