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Iovance Biotherapeutics Study Team 1-844-845-4682
Clinical.Inquiries@iovance.com


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Be Part of Research - Trial Details - Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors
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Study of Autologous Tumor Infiltrating Lymphocytes in Patients With Solid Tumors

Recruiting

Open to: ALL

Age: 12.0 - N/A

London London Bristol

Medical Conditions

Squamous Cell Carcinoma of Head and Neck

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

May 2019 Aug 2029

Publications

"Hensel J, Metts J, Gupta A, Ladle BH, Pilon-Thomas S, Mullinax J. Adoptive Cellular Therapy for Pediatric Solid Tumors: Beyond Chimeric Antigen Receptor-T Cell Therapy. Cancer J. 2022 Jul-Aug 01;28(4):322-327. doi: 10.1097/PPO.0000000000000603."; "35880942"

INTERVENTIONAL

Intervention Type : BIOLOGICAL
Intervention Description : A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with Lifileucel followed by IL-2 administration. Lifileucel will be administered to patients once (on Day 0) during the study.

Intervention Arm Group : Cohort 1A;Cohort 1C;

Intervention Type : BIOLOGICAL
Intervention Description : A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.

Intervention Arm Group : Cohort 2A;Cohort 3A;Cohort 3B;Cohort 3C;

Intervention Type : DRUG
Intervention Description : Humanized antibody.

Pembrolizumab will be administered following tumor resection and will continue every 3 weeks or every 6 weeks thereafter for up to 2 years.

Intervention Arm Group : Cohort 1A;Cohort 2A;Cohort 3A;

Intervention Type : BIOLOGICAL
Intervention Description : A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145-S1) followed by IL-2 administration. TIL will be administered to patients once (on Day 0) during the study.

Intervention Arm Group : Cohort 1B;

Intervention Type : DRUG
Intervention Description : Monoclonal antibody

Ipilimumab will be administered as a single dose prior to tumor resection.

Intervention Arm Group : Cohort 3C;

Intervention Type : DRUG
Intervention Description : Monoclonal antibody

Nivolumab will be administered once prior to tumor resection. The second dose will be administered prior to TIL administration and dosing will continue every 4 weeks for up to 2 years.

Intervention Arm Group : Cohort 3C;



You can take part if:



You may not be able to take part if:


This is in the inclusion criteria above


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • The Royal Marsden NHS Foundation Trust
    London
    England
    SW3 6JJ
  • Guy's Hospital
    London
    England
    SE19RT
  • Bristol Haematology and Oncology Centre
    Bristol
    BS2 8ED

Iovance Biotherapeutics Study Team 1-844-845-4682
Clinical.Inquiries@iovance.com



The study is sponsored by Iovance Biotherapeutics, Inc.



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Read full details for Trial ID: NCT03645928
Last updated 04 April 2024

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