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Unresectable or Metastatic MelanomaEarly Phase 1PICSTATNCT07700121

PICSTAT Pilot Study for CD8 PET/CT-Guided Lifileucel Treatment in Advanced Melanoma

A Early Phase 1 study testing Resection of PET (high) and PET (low) Tumors, Lifileucel Manufacturing Clinical v Research and Chemotherapy Regimen in people with Unresectable or Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Unresectable or Metastatic Melanoma
What is being tested?
Resection of PET (high) and PET (low) Tumors, Lifileucel Manufacturing Clinical v Research and Chemotherapy Regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 Oct 2029
Phase
Early Phase 1
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

  • Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV)
  • Participants must have progressed following ≥ 1 prior systemic therapy for Stage IV or unresectable Stage III disease including a PD- 1 blocking antibody; and if BRAF V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with MEK inhibitor.
  • At least two resectable previously non-irradiated lesions (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post- resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
  • Lesions in the spleen should not be selected as resectable lesions, because they are not well evaluated by CD8 PET/CT imaging due to high background signal in that organ
  • In addition to the two resectable lesions, at least one measurable target lesion, as defined by RECIST v1.1
  • 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
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  • 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
  • Participants must be ≥ 18 years of age at the time of consent.
  • Participants must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 .
  • Participants must have signed informed consent for the PICSTAT companion CD8 PET imaging protocol.
  • Participants are eligible for treatment with AMTAGVI per the recommendation of the treating oncologist.
  • Participant (or legally authorized representative) is capable of giving signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Participants of childbearing potential or their partners of childbearing potential must be willing to take the appropriate precaution to avoid pregnancy or fathering a child for the duration of the protocol and practice an approved, highly effective method of birth control during treatment and for 12 months after receiving the last protocol-related therapy
  • Palliative radiation therapy is permitted so long as it does not involve lesions being selected for TIL, or as target or non-target lesions. Washout is not required if all related toxicities have resolved to ≤ Grade 1 as per CTCAE v 6.0.

Who cannot join

  • Participants who have received an organ allograft or prior cell transfer therapy within the past 20 years that included a non-myeloablative or myeloablative chemotherapy regimen.
  • Participant has melanoma of uveal/ocular origin.
  • Participants who have a history of hypersensitivity to any component or excipient of lifileucel (AMTAGVI) or other study drugs: a. Hypersensitivity to PET tracer b. LD chemo regimen (cyclophosphamide, mesna, and fludarabine) c. Proleukin®, aldesleukin, IL-2 d. Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); (These participants may be eligible if current hypersensitivity has been excluded.) e. Any component of the lifileucel infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
  • Participant has symptomatic untreated brain metastases. Participants with brain metastases may be considered for study participation with the following considerations and only after discussion with the Investigator:
  • 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).
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  • 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.
  • Participant requires systemic steroid therapy > 10 mg/day of prednisone or another steroid equivalent dose.
  • Participants receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or another steroid equivalent dose may be eligible
  • Participant has evidence of any active viral, bacterial, or fungal infection requiring ongoing systemic treatment or identified during screening
  • Participants who are pregnant or breastfeeding.
  • Participants who have active medical illness(es) that would pose increased risk for study participation, including: active uncontrolled infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
  • Participants who have received or will receive a live or attenuated vaccination within 28 days prior to the start of LD chemo regimen.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ravi Amaravadi, MD contact

215-796-5159

Ravi.Amaravadi@pennmedicine.upenn.edu

United States1 site

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

    Ravi Amaravadi, MD, 215-796-5159, Ravi.Amaravadi@pennmedicine.upenn.edu

    Ravi Amaravadi, MD

Other trials in United States

About this study

Official title: PICSTAT (PET Imaging of CD8 for Selection of Tumors for Autologous TIL): A Pilot Study Assessing the Use of CD8 PET/CT (Zr-89 Crefmirlimab Berdoxam) to Enhance Lifileucel (AMTAGVI) Efficacy in Patients With Treatment Refractory Stage IV Melanoma

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.

Being tested
Resection of PET (high) and PET (low) Tumors, Lifileucel Manufacturing Clinical v Research, Chemotherapy Regimen, Lifileucel Infusion, IL-2
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Resection of PET (high) and PET (low) TumorsProcedure or surgery

    Harvest of two tumors to obtain tissue for manufacturing the autologous tumor-infiltrating lymphocyte (TIL) cellular product.

  • Lifileucel Manufacturing Clinical v ResearchBiological

    Production of lifileucel (AMTAGVI) for participant infusion) and comparator lifileucel (AMTAGVI) at a centralized Good Manufacturing Practice (GMP)-compliant facility.

  • Chemotherapy RegimenDrug

    Administration of a 7-day lymphodepleting (LD) chemotherapy regimen prior to lifileucel infusion.

  • Lifileucel InfusionBiological

    Administration of CD8 PET-guided infusion of lifileucel (AMTAGVI) on Day 0 following completion of the lymphodepleting chemotherapy regimen.

  • IL-2Drug

    Administration of up to six doses of intravenous interleukin-2 (IL-2) following lifileucel (AMTAGVI) infusion.

  • CD8 PETProcedure or surgery

    CD8 PET/CT imaging will be performed before tumor resection and after lifileucel (AMTAGVI) administration (PET1).

Study groups in NCT07700121
Study groupRoleWhat they receive
CD8 PET/CT imaging for lifileucel therapyExperimentalCD8 PET/CT imaging prior to tumor resection (PET0) and after lifileucel treatment.
Receives: Procedure: Resection of PET (high) and PET (low) Tumors; Biological: Lifileucel Manufacturing Clinical v Research; Drug: Chemotherapy Regimen; Biological: Lifileucel Infusion; Drug: IL-2; Procedure: CD8 PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. TILs

    Number of viable TILs (cell count) harvested from resected tumor tissue.

    Measured: 8-12weeks

Secondary outcomes (5)

  1. Overall response rate (ORR)

    ORR as assessed by the Investigator per RECIST 1.1

    Measured: 4-12 weeks

  2. Complete Response (CR) rate

    CR rate as assessed by the Investigator per RECIST 1.1

    Measured: 4-12 months

  3. Treatment-emergent adverse events (TEAEs)

    Incidence of Grade ≥ 3 TEAEs

    Measured: 3-4 months

  4. Duration of response (DOR)

    DOR as assessed by the Investigator

    Measured: 12 months

  5. Progression-free survival (PFS)

    PFS, as assessed by the Investigator

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 Oct 2028 (estimated)
  4. Study completion1 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07700121
Sponsor's protocol ID
UPCC 05626
Other IDs
26-7163
Acronym
PICSTAT
Status last verified
Jul 2026
First submitted
7 Jul 2026
Last updated
13 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Resection of PET (high) and PET (low) Tumors, Lifileucel Manufacturing Clinical v Research and Chemotherapy Regimen in people with Unresectable or Metastatic Melanoma, run by Abramson Cancer Center at Penn Medicine 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 14 inclusion and 13 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 13 Jul 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.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 Ravi Amaravadi, MD (215-796-5159, Ravi.Amaravadi@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

TILs (time frame: 8-12weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07700121.

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 13 Jul 2026.

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