RecruitingPhase 1NCT06660420
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)
Sponsor
M.D. Anderson Cancer Center
Enrollment
39 participants
Start Date
Feb 25, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
To find the highest tolerable dose and recommended dose of PRAME-TCR-NK cells that can be given to participants with recurrent and/or refractory melanoma. The safety and tolerability of PRAME-TCR-NK cells will also be studied.
Eligibility
Min Age: 18 Years
Plain Language Summary
Simplified for easier understanding
This early-phase study tests a new cell therapy called PRAME-TCR-NK cells — immune cells engineered to recognize and attack melanoma — in people with advanced or metastatic melanoma that stopped responding to immunotherapy drugs like anti-PD-1 or anti-CTLA-4.
**You may be eligible if...**
- You are 18 or older with advanced, unresectable, or metastatic melanoma
- Your melanoma has stopped responding to at least one immunotherapy regimen
- You carry a specific immune marker called HLA-A*02:01
- You are generally well enough to carry out daily activities (ECOG 0–1)
- Your life expectancy is at least 3 months
- You have received no more than 3 prior lines of anti-PD-1 therapy
**You may NOT be eligible if...**
- You do not carry the HLA-A*02:01 marker
- You have untreated brain metastases
- You are pregnant or planning to become pregnant
Talk to your doctor to see if this trial is right for you.
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
DRUGCyclophosphamide
Given by IV
DRUGFludarabine
Given by IV
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06660420
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