Can a PET scan find the best tumor site for harvesting Cancer-Fighting cells?
NCT ID NCT07819474
First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time
Summary
Researchers are testing whether a PET scan that highlights CD8 immune cells can show the best place to collect tumor-infiltrating lymphocytes (TILs) from patients with advanced melanoma. Participants receive standard TIL therapy and also undergo an extra tumor sample from the site with the highest CD8 signal. The study aims to see if CD8 levels at the collection site are linked to how well patients respond to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Crefmirlimb, a tumor-infiltrating lymphocyte (TIL) therapy
- What this could lead to
- If the approach works, doctors could use CD8-PET scans to pick the best tumor site for collecting TIL cells and to predict which patients with advanced melanoma will respond to treatment.
- What could go wrong
- This is a very small study with only 6 participants, so the results may not apply to larger groups. The imaging approach may not reliably predict treatment response, and collecting extra tumor samples carries minor surgical risks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Aug 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \<18 years of age, children are excluded from this study. * The effects of crefmirlimab on the developing human fetus are unknown. For this reason and because standard-of-care TIL used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female Participants, between the onset of menses (as early as 8 years of age) and 55 years unless the Participant presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. * Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. * Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of \[Agent\] administration. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria * 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. * Pregnant women are excluded from this study because crefmirlimab is radioactive substance with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants' secondary to treatment of the mother with crefmirlimab, breastfeeding should be discontinued if the mother is treated with crefmirlimab. These potential risks may also apply to other agents used in this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UT MD Anderson Cancer Center
Houston, Texas, 77030, United States
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- New combo therapy takes on advanced cancers
- Wheat germ supplement studied for immune boost in advanced cancer