TheranosticTrials.org

Clinical Trial · NCT07700121

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

Overview

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.

Sponsor

Abramson Cancer Center of the University of Pennsylvania

Phase

Early Phase 1

Contacts

Ravi Amaravadi, MD (CONTACT)

ravi.amaravadi@pennmedicine.upenn.edu

215-796-5159

Ravi Amaravadi, MD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07700121

Drug / Compound

crefmirlimab berdoxam

Isotope(s):
Target(s):
  • CD8 Cells
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • Must have a confirmed diagnosis of unresectable or metastatic melanoma (Stage IV)
  • Participants are eligible for treatment with AMTAGVI per the recommendation of the treating oncologist.

Exclusion

  • Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.
  • 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:
  • 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 has melanoma of uveal/ocular origin.