Trial Summary
What is the purpose of this trial?
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 Criteria
This trial is for people with melanoma that has come back or hasn't responded to treatment. Participants must meet certain health requirements, which will be specified by the researchers conducting the study.Inclusion Criteria
I am willing to have blood tests and biopsies.
Participants must have measurable disease per the Response Evaluation Criteria in Solid Tumors (RECIST)
I agree not to get a live vaccine for 2 years after my treatment.
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Exclusion Criteria
Not recovered from all adverse events due to previous therapies
Psychiatric or substance abuse disorders that would interfere with study cooperation
I have had another type of cancer in the past 2 years.
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Treatment Details
Interventions
- PRAME T Cell Receptor (TCR) Engineered NK Cells (CAR T-cell Therapy)
Trial OverviewResearchers are testing PRAME-TCR-NK cells at various doses to find the highest dose patients can tolerate without severe side effects. They're also looking for a recommended safe dose and assessing overall safety.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Expansion PhaseExperimental Treatment2 Interventions
Participants will receive PRAME-TCR-NK cells at the recommended dose.All participants will receive the same dose level of fludarabine and cyclophosphamide
Group II: Escalation PhaseExperimental Treatment2 Interventions
The dose of PRAME-TCR-NK cells you receive will depend on when you join this study. Up to 5 dose levels of the study product will be tested. The first group of participants will receive the lowest dose level of the study product. Each new group will receive a higher dose of the study product than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose and recommended dose of the study product is found.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MD Anderson Cancer CenterHouston, TX
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Who Is Running the Clinical Trial?
M.D. Anderson Cancer CenterLead Sponsor