M.D. Anderson Cancer Center
To find out if the amount of CD8 immune cells at the place where TIL cells are collected is linked to how well a patient responds to treatment.
Primary Objective(s) and Endpoint(s) To identify TIL harvest site factors, using CD8-PET imaging, that mediate response by Isolating the impact of CD8 infiltration at the TIL harvest site on response (based on RECIST 1.1) at 90 days after TIL infusion. To determine imaging features on pre-TIL CD8-PET that are associated with response.
Inclusion Criteria * Participants must have histologically confirmed advanced melanoma and have been selected for, eligible for, and consented for treatment with standard-of-care TIL (Iovance). * Participants must have two additional metastases that are measurable based on RECIST 1.1 criteria, one of which must have low surgical morbidity, defined as dermal, subcutaneous, soft tissue, or nodal metastasis not requiring entry into the abdominal or pelvic cavity to harvest. * Age ≥18 years. Because no dosing or adverse event data are currently available on the use of crefmirlimab in Participants…
Given by Iv
An additional excision, for research purposes only, will be performed from the site with the highest CD8 PET SUVmean as long as it is a dermal, subcutaneous, soft tissue, or nodal metastasis that does not require entry into the abdomen or pelvis and does not correspond to the planned standard-of-care harvest site.
Arctuva estimate
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