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.
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 <18 years of age, children are excluded from this study.
Postmenopausal (no menses in greater than or equal to 12 consecutive months).
Participants who are not eligible and consented for standard-of-care Iovance TIL therapy.
Participants who are due to receive standard-of-care Iovance TIL therapy in less than 28 days.
Participants who are receiving any other investigational agents.
Participants with psychiatric illness/social situations that would limit compliance with study requirements.
Single group
Crefmirlimb
DrugGiven by Iv
PET/CT imaging
DeviceAn 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.
safety and adverse events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Click on the lead sponsor to view all of their trials.
M.D. Anderson Cancer Center
Lead sponsor
ImaginAb, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
