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.

NCT06660420

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)

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~39 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:CyclophosphamideFludarabine

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year
Phase 1
Recurrent Melanoma
Refractory Melanoma
1 sites across 1 states
Texas1
  • Isabella C Glitza Oliva, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

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  • 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