Optimizing Tumor-Infiltrating Lymphocyte (TIL) Harvest Site and Patient Selection With CD8-PET Imaging in Patients With

NCT07819474 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 2026-0860NCI-2026-06813
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

CD8-PET; Advanced Melanoma; Tumor Infiltrating Lymphocyte

Outcome Measures

Primary Outcomes (1)

• 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

  Through study completion; an average of 1 year.

Study Arms (1)

Treatment with Crefmirlimab (IV)

EXPERIMENTAL

Patients will undergo baseline research evaluation with a single crefmirlimab infusion on Day 0

Drug: Crefmirlimb; Device: PET/CT imaging

Interventions

Crefmirlimb DRUG

Given by Iv

Treatment with Crefmirlimab (IV)

PET/CT imaging DEVICE

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.

Treatment with Crefmirlimab (IV)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• ImaginAb, Inc.: collaborator

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

Study Officials

• Ashley M Holder, MD

  UT MD Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ashley M Holder, MD

CONTACT

713-794-1001; AMHolder@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2026
• First Posted: September 15, 2026
• Study Start (Estimated): February 18, 2027
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2030
• Last Updated: September 15, 2026

Record last verified: 2026-09

Locations

US (1)