In short
Autologous tumor-infiltrating T lymphocytes (TILs), ex vivo expanded with interleukin-7, interleukin-15 and interleukin-21, are an investigational adoptive cell therapy. In the EU Clinical Trials Information System, this substance is the subject of one withdrawn Phase 1 trial in children and young adults with high-risk relapsed/refractory neuroblastoma, which planned to enroll 15 participants.
Key points
- Autologous tumor-infiltrating T lymphocytes (TILs) are a patient's own immune cells, expanded in the laboratory with three interleukins.
- The only EU-registered trial for this substance was a Phase 1 feasibility study in high-risk relapsed/refractory neuroblastoma.
- The trial was withdrawn before enrolling participants.
- The planned enrollment was 15 children and young adults.
- The primary endpoint was dose-limiting toxicity of the combination of TILs and AloCelyvir.
- Both TILs and AloCelyvir were to be given by intravenous infusion.
What is autologous tumor-infiltrating T lymphocytes?
Autologous tumor-infiltrating T lymphocytes, ex vivo expanded with interleukin-7, interleukin-15 and interleukin-21, are an investigational adoptive cell therapy. The term "autologous" means the cells come from the patient's own body. Tumor-infiltrating lymphocytes (TILs) are a type of immune cell, specifically T cells, that have moved into a tumor. In this therapy, these cells are taken from the tumor, multiplied and activated in the laboratory using three signalling proteins called interleukins (interleukin-7, interleukin-15 and interleukin-21), and then given back to the patient by intravenous infusion. No trade name or marketing authorisation is listed for this substance in the trial record, indicating it remains an investigational product.
How does autologous tumor-infiltrating T lymphocytes work?
Tumor-infiltrating lymphocytes are a mixed population of T cells that can recognise several different proteins (antigens) present on a patient's own tumor cells. However, TILs taken from a tumor may be in an "exhausted" state, meaning they are less able to attack the cancer effectively. Expanding these cells outside the body with interleukins aims to increase their number and restore their ability to fight the tumor when given back to the patient. A related research approach, described in a supplementary source, uses a small-molecule drug during expansion to create "drug-enhanced TILs" with improved persistence and tumor-killing function compared with conventional TILs. The specific role of interleukins 7, 15 and 21 in this product is to support the growth and activation of the T cells during laboratory expansion.
Which conditions is it used or studied for?
In the EU clinical trial record, this substance was being studied for one condition:
- High-risk relapsed/refractory neuroblastoma — a cancer of developing nerve cells in children and young adults that has come back after treatment (relapsed) or has not responded to treatment (refractory).
How is autologous tumor-infiltrating T lymphocytes given?
In the planned trial, the TIL product was to be administered by intravenous bolus injection or intravenous infusion. This means the cells would be given directly into a vein, either as a quick injection or as a slower drip over a period of time. The trial record does not specify a dose.
What do the clinical trials show?
The EU Clinical Trials Information System contains one trial record for this substance: a Phase 1 feasibility study in children and young adults with high-risk relapsed/refractory neuroblastoma. The trial planned to enroll 15 participants and was designed to test the safety and tolerability of the TIL product when given sequentially with another investigational product, AloCelyvir. The primary endpoint was dose-limiting toxicity (DLT), which measures the side effects that prevent a dose from being safely increased or continued. The trial status is "withdrawn," meaning the study was stopped before it began enrolling participants. Because the trial was withdrawn, no efficacy or safety results are available from this record.
What side effects are known?
The withdrawn trial record does not report any side effects. The supplementary source describes a Phase 1 study of a related drug-enhanced TIL product and states that the primary objectives were to evaluate safety and tolerability, but does not provide a list of side effects. Therefore, no specific side effects for this substance can be reported from the available data.