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.

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Updated on 7 April 2022

See if I qualify

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 Identifier	NCT03645928
Sponsor	Iovance Biotherapeutics, Inc.
Last Modified on	7 April 2022

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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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Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors