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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Advanced Melanoma; Tumor Infiltrating Lymphocyte; CD8-PET
• Intervention / Treatment: Drug: Crefmirlimb; Device: PET/CT imaging

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ashley M Holder, MD; Phone Number: 713-794-1001; Email: AMHolder@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • UT MD Anderson Cancer Center
      • Contact: Ashley M Holder, MD; Phone Number: 713-794-1001; Email: AMHolder@mdanderson.org
      • Principal Investigator: Ashley M Holder, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with Crefmirlimab (IV); Patients will undergo baseline research evaluation with a single crefmirlimab infusion on Day 0	Drug: Crefmirlimb; Given by Iv; Device: PET/CT imaging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: ImaginAb, Inc.
• Investigators: Principal Investigator: Ashley M Holder, MD, UT MD Anderson Cancer Center

Publications and helpful links

Helpful Links

• UT MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Estimated): February 18, 2027
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: September 10, 2026
• First Submitted That Met QC Criteria: September 10, 2026
• First Posted (Actual): September 15, 2026

Study Record Updates

• Last Update Posted (Actual): September 15, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 2026-0860; NCI-2026-06813 (Other Identifier: NCI-CTRP Clinical Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No