PICSTAT Pilot Study for CD8 PET/CT-Guided Lifileucel Treatment in Advanced Melanoma (NCT07700121) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
PICSTAT Pilot Study for CD8 PET/CT-Guided Lifileucel Treatment in Advanced Melanoma
United States10 participantsStarted 2026-10-01
Plain-language summary
This prospective, single-center pilot study is being performed to find out whether Zr-89 crefmirlimab berdoxam "CD8 PET/CT" scans can improve the effectiveness of the tumor-infiltrating lymphocyte (TIL) therapy called lifileucel ("Study Treatment") in treating metastatic melanoma.
Participants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion
. If a lesion is partially resected to generate TIL, and remains visible on the Baseline scan after surgery, then the partially resected lesion can be used for RECIST v1.1 response assessment, but only as a non- target lesion
Exclusion criteria
. Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.
. A participant with historically treated brain metastases (i.e., treatment was completed \>28 days prior to consenting for study participation) may be considered for study participation if the participant is clinically stable for ≥ 2 weeks, there are no new or worsening brain lesions via screening CT or MRI, and the participant does not require ongoing corticosteroid treatment (\>10 mg/day prednisone or equivalent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. If there are progressive or new brain metastases on the screening CT or MRI, the participant should first receive treatment for them prior to restarting or continuing screening. A participant with recently treated brain metastases (i.e., treatment of brain metastases was completed ≤ 28 days prior to consenting for study participation) may be considered for study participation if the participant is asymptomatic, clinically stable for ≥ 2 weeks, and does not require corticosteroids (\>10 mg/day prednisone or equivalent) by the end of the screening period. Repeat brain imaging is not required after treatment.