Autologous TIL in Patients with Solid Tumours
Research type
Research Study
Full title
A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors
IRAS ID
249778
Contact name
Heather Shaw
Contact email
Sponsor organisation
Iovance Biotherapeutics, Inc.
Eudract number
2018-001608-12
Duration of Study in the UK
3 years, 9 months, 31 days
Research summary
The study is designed to evaluate Adoptive Cell Therapy (ACT) with tumour infiltrating (found within) lymphocytes (TIL) LN-144/LN-145 as a single-therapy or in combination with pembrolizumab (Keytruda®) for patients with Metastatic Melanoma (MM), Head and neck squamous cell carcinoma (HNSCC) or Non-small-cell lung cancer (NSCLC) LN-145 therapy alone.
Participants will be assigned to the cohort (treatment group) that matches their disease type.
TIL (LN-144/LN-145) is made up of specialised white blood cells called lymphocytes or “T cells” found within the patient’s tumour, after a small piece is surgically removed from the patient. The process involves the collection and growth in a laboratory of ‘T cells’ (white blood cells) found inside the patient’s tumour, then infused (given back to participants through a vein) back into the participants body. The Investigational Drug TIL (LN-144/LN-145) is given with other medications that together make up the therapy. This includes receiving a preconditioning regimen of chemotherapy medications (cyclophosphamide and fludarabine). These are two chemotherapy drugs that prepares the patient's body to receive TIL (LN-144/LN-145) in a way that allows the ‘T cells’ the best opportunity to attack the patients tumour. After the TIL (LN-144/LN-145) infusion, participants will receive a medication called interleukin-2 (IL-2, Proleukin®), a naturally occurring protein, that helps white blood cells/T cells to be more effective against cancer cells.
To date, TIL (LN-144/LN-145) has been given to over 82 humans, who have participated in clinical research studies sponsored by Iovance Biotherapeutics, Inc.
This is a multicentre study of Autologous TIL (LN-144 or LN-145) in participants with Solid Tumours, funded by Iovance Biotherapeutics, Inc., Approximately 36 participants will be recruited globally with around 4 participants to be recruited in the UK. Participation will be up to 5 years from LN144-145 treatment day and follow-up.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0086
Date of REC Opinion
6 Jun 2019
REC opinion
Further Information Favourable Opinion