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.
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
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.
Participants with asymptomatic brain metastases who do not clinically require treatment may be considered for study participation.
Single group
Resection of PET (high) and PET (low) Tumors
Procedure/SurgeryHarvest of two tumors to obtain tissue for manufacturing the autologous tumor-infiltrating lymphocyte (TIL) cellular product.
Lifileucel Manufacturing Clinical v Research
Biological/VaccineProduction of lifileucel (AMTAGVI) for participant infusion) and comparator lifileucel (AMTAGVI) at a centralized Good Manufacturing Practice (GMP)-compliant facility.
Chemotherapy Regimen
DrugAdministration of a 7-day lymphodepleting (LD) chemotherapy regimen prior to lifileucel infusion.
Lifileucel Infusion
Biological/VaccineAdministration of CD8 PET-guided infusion of lifileucel (AMTAGVI) on Day 0 following completion of the lymphodepleting chemotherapy regimen.
IL-2
DrugAdministration of up to six doses of intravenous interleukin-2 (IL-2) following lifileucel (AMTAGVI) infusion.
CD8 PET
Procedure/SurgeryCD8 PET/CT imaging will be performed before tumor resection and after lifileucel (AMTAGVI) administration (PET1).
TILs
Number of viable TILs (cell count) harvested from resected tumor tissue.
Overall response rate (ORR)
ORR as assessed by the Investigator per RECIST 1.1
Complete Response (CR) rate
CR rate as assessed by the Investigator per RECIST 1.1
Treatment-emergent adverse events (TEAEs)
Incidence of Grade ≥ 3 TEAEs
Duration of response (DOR)
DOR as assessed by the Investigator
Correlation of T cell
Correlation of T cell clonotype, T cell phenotype, with CD8 PET measures, response, percent reduction in target lesion sum of diameters, and toxicity following lifileucel (AMTAGVI) therapy.
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Abramson Cancer Center at Penn Medicine
Lead sponsor
Iovance Biotherapeutics, Inc.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
