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

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT07700121
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Unresectable or Metastatic Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Resection of PET (high) and PET (low) Tumors — PROCEDURE
    Harvest of two tumors to obtain tissue for manufacturing the autologous tumor-infiltrating lymphocyte (TIL) cellular product.
  • Lifileucel Manufacturing Clinical v Research — BIOLOGICAL
    Production of lifileucel (AMTAGVI) for participant infusion) and comparator lifileucel (AMTAGVI) at a centralized Good Manufacturing Practice (GMP)-compliant facility.
  • Chemotherapy Regimen — DRUG
    Administration of a 7-day lymphodepleting (LD) chemotherapy regimen prior to lifileucel infusion.
  • Lifileucel Infusion — BIOLOGICAL
    Administration of CD8 PET-guided infusion of lifileucel (AMTAGVI) on Day 0 following completion of the lymphodepleting chemotherapy regimen.
  • IL-2 — DRUG
    Administration of up to six doses of intravenous interleukin-2 (IL-2) following lifileucel (AMTAGVI) infusion.
  • CD8 PET — PROCEDURE
    CD8 PET/CT imaging will be performed before tumor resection and after lifileucel (AMTAGVI) administration (PET1).

Study Details

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.

Key Dates

First listed
Jul 13, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2028
Completion
Oct 1, 2029

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD8 PET/CT imaging for lifileucel therapy
    CD8 PET/CT imaging prior to tumor resection (PET0) and after lifileucel treatment.

Primary Outcome Measure

TILs [ Time Frame: 8-12weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Abramson Cancer Center of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Ravi Amaravadi, MD
[email protected]
215-796-5159
Ravi Amaravadi, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Abramson Cancer Center of the University of Pennsylvania· Philadelphia, PA