MedTrace Logo

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

NCT07700121 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-07-13

No results posted yet for this study

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.

Participants must first provide consent to the companion protocol (UPCC 19426, PICSTAT CD8 PET) before being eligible to consent to this protocol.

Conditions

  • Unresectable or Metastatic Melanoma

Interventions

PROCEDURE

Resection of PET (high) and PET (low) Tumors

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

BIOLOGICAL

Lifileucel Manufacturing Clinical v Research

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

DRUG

Chemotherapy Regimen

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

BIOLOGICAL

Lifileucel Infusion

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

DRUG

IL-2

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

PROCEDURE

CD8 PET

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

Sponsors & Collaborators

  • Iovance Biotherapeutics, Inc.

    collaborator INDUSTRY

  • Abramson Cancer Center at Penn Medicine

    lead OTHER

Principal Investigators

  • Ravi Amaravadi, MD · Abramson Cancer Center at Penn Medicine

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2028-10-01
Completion
2029-10-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07700121 on ClinicalTrials.gov