A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic … (NCT05607095) | Clinical Trial Compass
RecruitingPhase 1
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
United States30 participantsStarted 2022-11-01
Plain-language summary
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.
* Patients will be eligible regardless of the number of prior systemic therapies received.
* 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 onocologist as either (a) low liklihood 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
* Patients who refuse standard of care chemotherapy will be eligible
* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).
* Patients must be ≥ 18 years of age at the time of consent.
* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.
* Patients must have the following hematologic parameters:
* Absolute neutrophil count (ANC) ≥ 1000/mm3
* Hemoglobin (Hb) ≥ 9.0 g/dL
* Platelet ≥ 100,000/mm\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the…