Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

  • STATUS
    Recruiting
  • End date
    Dec 7, 2024
  • participants needed
    135
  • sponsor
    Iovance Biotherapeutics, Inc.
Updated on 7 April 2022
cancer
systemic therapy
measurable disease
carcinoma
squamous cell carcinoma
lung cancer
pembrolizumab
EGFR
nivolumab
solid tumour
stage iv non-small cell lung cancer
head and neck carcinoma
metastatic squamous cell carcinoma
lung carcinoma

Summary

A prospective, open-label, multi-cohort, non-randomized, multicenter Phase 2 study evaluating adoptive cell therapy (ACT) with TIL LN-144 (Lifileucel)/LN-145 in combination with checkpoint inhibitors or TIL LN-144 (Lifileucel)/LN-145/LN-145-S1 as a single agent therapy.

Description

LN-144 (Lifileucel)/LN-145/LN-145-S1 is an adoptive cell transfer therapy that utilizes an autologous TIL for the treatment of patients with unresectable or metastatic melanoma, advanced, recurrent, or metastatic squamous cell carcinoma of the head and neck, and locally advanced or metastatic non-small cell lung cancer. The adoptive cell transfer therapy used in this study involves patients receiving a nonmyeloablative (NMA) lymphodepletion regimen, followed by infusion of autologous TIL followed by the administration of a regimen of IL-2. Patients in Cohorts 1A, 2A, 3A and 3C will receive TIL plus checkpoint inhibitors. Patients in Cohorts 1B, 1C, and 3B will receive autologous TIL as a single therapy.

Details
Condition Metastatic Melanoma, Squamous Cell Carcinoma of the Head and Neck, Non-small Cell Lung Cancer
Treatment Ipilimumab, Pembrolizumab, Nivolumab, LN-145, Lifileucel, LN-145-S1
Clinical Study IdentifierNCT03645928
SponsorIovance Biotherapeutics, Inc.
Last Modified on7 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma Stage IIIC or Stage IV (Cohorts 1A,1B and 1C), advanced, recurrent or metastatic HNSCC (Cohort 2A), or Stage III or Stage IV non-small cell lung cancer (Cohorts 3A, 3B, and 3C)
Cohorts 1A, 2A, and 3A: If previously treated, patients must have progressed on or after most recent therapy and must not have received CPIs as part of one of the counted lines of prior therapy. Patients must have radiologically documented disease progression while receiving or after the completion of the most recent prior treatment. Patients may have received up to 3 prior systemic anticancer therapies (except for Cohort 3A, where patients whose tumors harbor actionable mutations may have received up to 4 prior systemic therapies)
Cohorts 1B, 1C, 3B, and 3C: Unresectable or metastatic melanoma patients in Cohorts 1B or 1C must have previously received systemic therapy with a PD-1 blocking antibody. NSCLC patients in Cohort 3B must have previously received systemic therapy with any CPI (except for those patients with known oncogene drivers (eg, EGFR, ALK, ROS) who have mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines of therapy. NSCLC patients in Cohort 3C must have received prior systemic therapy with an approved monotherapy CPI as their single prior line of systemic therapy
Must have at least 1 resectable lesion
Must have a remaining measurable disease as defined by RECIST 1.1 following tumor resection
Must be ≥ 18 years at the time of consent for Cohorts 1A, 1C, 2A, 3A, 3B, and 3C. Patients must be ≥ 12 years at the time of consent for Cohort 1B. Enrollment of patients > 70 years of age may be allowed after consultation with the Medical Monitor
Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and an estimated life expectancy of ≥ 6 months
Patients of childbearing potential or those with partners of childbearing potential must be willing to practice an approved method of birth control during treatment and for 12 months after receiving all protocol-related therapy

Exclusion Criteria

Patients with melanoma of uveal/ocular origin
Patients who have received an organ allograft or prior cell transfer therapy that included a nonmyeloablative or myeloablative chemotherapy regimen within the past 20 years
Patients with symptomatic and/or untreated brain metastases
Patients who are on systemic steroid therapy ≥ 10 mg/day of prednisone or other steroid equivalent. Patients receiving steroids as replacement therapy for adrenocortical insufficiency at ≤ 10 mg/day of prednisone or other steroid equivalent may be eligible
Patients who are pregnant or breastfeeding
Patients who have an active medical illness(es), which in the opinion of the Investigator, would pose increased risks for study participation
Cohort 1A, 2A, 3A, and 3C patients may not have a medical history of autoimmune disorders (including pneumonitis) requiring treatment or active management
Patients who have received a live or attenuated vaccination within 28 days prior to the start of treatment
Patients who have any form of primary immunodeficiency
Patients with a history of hypersensitivity to any component of the study drugs
Patients who have a left ventricular ejection fraction (LVEF) < 45% or who are New York Heart Association Class II or higher
Patients with respiratory dysfunction or history of smoking are excluded if not meeting either of forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 0.7 or FEV1 > 50%
Patients who have had another primary malignancy within the previous 3 years
Participation in another interventional clinical study within 21 days of the initiation of treatment
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