Tumor Infiltrating LymphocyteNCT07819474
Optimizing Tumor-Infiltrating Lymphocyte (TIL) Harvest Site and Patient Selection With CD8-PET Imaging in Patients With
A study testing Crefmirlimb and PET/CT imaging in people with Tumor Infiltrating Lymphocyte and CD8-PET, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumor Infiltrating Lymphocyte, CD8-PET, Advanced Melanoma
- What is being tested?
- Crefmirlimb and PET/CT imaging
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2027to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
UT MD Anderson Cancer Center
Houston, Texas, 77030
Ashley M Holder, MD, 713-794-1001, AMHolder@mdanderson.org
Ashley M Holder, MD
About this study
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.
Read the 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.
- Conditions
- Tumor Infiltrating Lymphocyte, CD8-PET, Advanced Melanoma
- Being tested
- Crefmirlimb, PET/CT imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrefmirlimbDrug
Given by Iv
PET/CT imagingDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with Crefmirlimab (IV) | Experimental | Patients will undergo baseline research evaluation with a single crefmirlimab infusion on Day 0 Receives: Drug: Crefmirlimb; Device: PET/CT imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start18 Feb 2027 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor Infiltrating LymphocyteStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- ImaginAb, Inc.
- Responsible party
- Sponsor
- Investigators
- Ashley M Holder, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07819474
- Sponsor's protocol ID
- 2026-0860
- Other IDs
- NCI-2026-06813
- Status last verified
- Sep 2026
- First submitted
- 10 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Tumor-Infiltrating Lymphocyte (TIL) Harvest Site and Patient Selection With CD8-PET Imaging in Patients With
- ClinicalTrials.gov ID
- NCT07819474
- Acronym / sponsor ID
- 2026-0860
- Conditions
- Tumor Infiltrating Lymphocyte, CD8-PET, Advanced Melanoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- ImaginAb, Inc.
- Study start
- 18 Feb 2027 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 15 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with Crefmirlimab (IV) | Experimental | Drug: Crefmirlimb, Device: PET/CT imagingPatients will undergo baseline research evaluation with a single crefmirlimab infusion on Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrefmirlimbGiven by Iv | Drug | Treatment with Crefmirlimab (IV) |
| PET/CT imagingAn 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. | Device | Treatment with Crefmirlimab (IV) |
Primary outcome
safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- UT MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashley M Holder, MD principal investigator
UT MD Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crefmirlimb and PET/CT imaging in people with Tumor Infiltrating Lymphocyte and CD8-PET, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashley M Holder, MD (713-794-1001, AMHolder@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and adverse events (AEs) (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.