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)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06660420


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