A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, Dedifferentiated Liposarcoma, or Angiosarcoma

ConditionsUveal Melanoma Melanoma Metastatic Uveal Melanoma Metastatic Melanoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

About this trial

This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.

Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy

Unresectable disease will be defined by an expert sarcoma surgical oncologist as either (a) low likelihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure

Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy

Disqualifiers

Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.

NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)

Proleukin®, aldesleukin, IL-2

Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity

Trial design

Design model

Parallel

Treatments tested in this trial

Lifileucel (LN-144/LN-145)
Biological/Vaccine
Lifileucel (LN-144/LN-145) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

Treatment groups

40 Participants

are divided into 3 treatment groups

Group A: Participants with Metastatic Uveal MelanomaExperimental treatment 1 intervention

Group B: Participants with Metastatic SarcomaExperimental treatment 1 intervention

Group C: Expansion Patients with angiosarcomaExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Adverse events as evaluated by CTCAE v5.0

Safety will be measured descriptively using CTCAE v5.0 for all patients who undergo surgical excision.

Time frame

Up to 3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

Iovance Biotherapeutics, Inc.

Collaborator

Source ClinicalTrials.gov

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