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Using patients' own immune cells to treat solid tumors

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN 144/LN-145/LN-145-S1) in Patients With Solid Tumors

Phase 2 Interventional Iovance Biotherapeutics, Inc. · NCT03645928

This study is testing whether using patients' own immune cells can help treat hard-to-reach solid tumors like melanoma, certain head and neck cancers, and lung cancer.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment245 (estimated)
Ages18 Years and up
SexAll
SponsorIovance Biotherapeutics, Inc. Industry-sponsored
Drugs / interventionspembrolizumab, ipilimumab, nivolumab, relatlimab, chemotherapy, prednisone
Locations45 sites (La Jolla, California and 44 other locations)
Trial IDNCT03645928 on ClinicalTrials.gov

What this trial studies

This Phase 2 study evaluates the effectiveness of autologous tumor infiltrating lymphocytes (TIL) therapy in patients with unresectable or metastatic melanoma, advanced squamous cell carcinoma of the head and neck, and non-small cell lung cancer. Participants will undergo a nonmyeloablative lymphodepletion regimen followed by the infusion of their own TIL, with some receiving additional immune checkpoint inhibitors. The study aims to assess the safety and efficacy of this cell therapy approach in various cohorts based on their specific cancer types and treatment histories.

Who should consider this trial

Good fit: Ideal candidates include patients with unresectable or metastatic melanoma, advanced squamous cell carcinoma of the head and neck, or non-small cell lung cancer who have progressed on prior therapies.

Not a fit: Patients with tumors harboring actionable mutations who have effective targeted therapies may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced solid tumors that are difficult to treat with conventional therapies.

How similar studies have performed: Other studies utilizing adoptive cell transfer therapies have shown promising results, indicating potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria

* Must have a confirmed diagnosis of malignancy of their receptive histologies: unresectable or metastatic melanoma Stage IIIC to 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). Stage IV NSCLC with no actionable mutations (EGFR, ALK, ROS1) with effective targeted therapy (Cohorts 3D and 3E).
* Cohorts 1A, 1D, 2A, 3A, 3D and 3E: If previously treated, patients must have progressed on or after most recent therapy and must not have received ICIs 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). Patients in Cohort 1D may have had no prior therapy for advanced disease. Patients in Cohorts 3D and 3E may have had no prior systemic therapy for Stage IV disease.
* 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 ICI (except for those patients with known oncogene driver mutations that are sensitive to targeted therapies) as part of 1 - 3 prior lines of therapy. NSCLC patients in Cohort 3C must have previously received 1 line of ICI monotherapy. No other systemic therapy for metastatic disease is allowed. Prior chemoradiation and/or chemotherapy in the adjuvant and/or neoadjuvant settings are allowed.
* Must have at least 1 resectable lesion
* Must have 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, 1D, 2A, 3A, 3B, 3C, 3D and 3E. 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 their last dose of aldesleukin, 4 months after their last dose of pembrolizumab, 5 months after their last dose of ipilimumab or nivolumab, or nivolumab-relatlimab; 6 months after the last dose of carboplatin; 14 months after the last dose of cisplatin; and 6 months after the last dose of pemetrexed, paclitaxel, or nab-paclitaxel, whichever occurs later.

Exclusion Criteria

* Patients with melanoma of uveal/ocular origin.
* Patients who have a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years. Patients being retreated with TIL, as part of this study are not excluded.
* Patients who have symptomatic, untreated brain metastases or history of leptomeningeal 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, 1D, 2A, 3A, 3C, 3D and 3E 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 to be administered in the pertinent cohort(s).
* Patients who have a left ventricular ejection fraction (LVEF) \< 45% or who are New York Heart Association Class II or higher. A cardiac stress test demonstrating any irreversible wall movement abnormality in any patients ≥60 years of age or in patients who have a history of ischemic heart disease, cardiac chest pain, or clinically significant atrial and/or ventricular arrhythmias.
* 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 prior to the initiation of treatment.
* Patients in Cohorts 1D, 3D, or 3E who previously received adjuvant or neoadjuvant ICI(s) for non-metastatic disease and had an immune-related AE(s) requiring systemic steroid treatment or discontinuation of immune checkpoint inhibitor therapy.

Where this trial is running

La Jolla, California and 44 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic MelanomaSquamous Cell Carcinoma of the Head and NeckNon-small Cell Lung CancerLN-144LN-145Cell TherapyAutologous Adoptive Cell TransferAutologous Adoptive Cell Therapy
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.