A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients with Metastatic Melanoma
Clinical Trial Information
Trial Contact: Valdez, Crystal; Donaldson, Karin M
IRB No: 17.069.06
Protocol Abbrev: C-144-01
Principal Investigator: Sajeve Samuel Thomas, MD
Phase: Drug: Phase II
Age Group: Adult
Secondary Protocol No: C-144-01
Treatment: autologous tumor infiltrating lymphocytes - non-cryopreserved product presentation/ chemotherapy
Therapies Involved: Chemotherapy
ClinicalTrials.gov ID: NCT02360579
Prospective, 3-cohort interventional study evaluating autologous tumor infiltrating lymphocyte (TIL) infusion (LN-144) followed by IL-2 after a non-myeloablative chemotherapy preparative regimen for the treatment of patients with metastatic melanoma.
To be eligible for the study, patients must meet ALL of the following criteria prior to enrollment
1.Patients must have measurable metastatic melanoma and at least one lesion that is resectable for TIL generation.
2.Patients must have undergone at least one prior systemic treatment for metastatic melanoma.
3.Patients must have either progressive disease or no response (i.e, no PR or CR) while receiving or after completion of most recent prior treatment.
4.Patients must be greater than 18 years of age at the time of consent. Enrollment of patients greater than 65 years of age can be done after consultation with the Medical Monitor.
5.Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6.In the opinion of the Investigator, patient must be capable of participating and completing study procedures.
7.Patients of child bearing age or potential must be willing to practice birth control during treatment and for four months after receiving all protocol related therapy.
8.Patients must have a serum absolute neutrophil count (ANC) greater than 1000/mm3, hemoglobin greater than 9.0 g/dL, and platelet count greater than 100,000/mm3.
9.Patients must have a serum ALT/SGPT and AST/SGOT less than three times the upper limit of normal (<3x ULN), a calculated creatinine clearance of greater than 50 mL/min (>50 mL/min), and a total bilirubin less than or equal to 2 mg/dL (≤ 2 mg/dL). Patients with Gilbert's Syndrome must have a total bilirubin less than 3 mg/dL (<3 mg/dL).
10.Patients must be seronegative for the HIV antibody, hepatitis B antigen, and hepatitis C antibody or antigen.
11.Patients must be EBV viral capsid antigen (VCA) IgG positive and/or, Epstein Barr nuclear antigen (EBNA) IgG positive, and have no clinical evidence of active EBV infection.
12.Patients must not have received systemic chemotherapy or immune therapy for 2 weeks (targeted therapy) and 4 weeks (all other anti-cancer therapy) at the time of enrollment, and there must be no intention of receiving any non-protocol systemic anti-cancer chemotherapy or immune therapy during the study period.
13.Patients with documented Grade 2 or greater diarrhea or colitis as a result of previous treatment with ipilimumab, tremelimumab, anti-PD1 or anti-PD-L1 antibodies must have been asymptomatic for at least 6 months or had a normal colonoscopy post treatment, with uninflamed mucosa by visual assessment.
14.Patients must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (ICF) approved by an institutional review board (IRB), and agree to abide by the study restrictions and return to the site for the required assessments.
15.Patients have provided written authorization for use and disclosure of protected health information.