In short
PEI 15-215 is an investigational cell therapy being studied in patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumour that occurs mainly in children. It is a dendritic cell vaccine prepared from the patient's own immune cells and loaded with tumour material. One Phase 1 trial is currently authorised, involving 15 patients, to evaluate the safety of this therapy in combination with CAR-T cells.
PEI 15-215 (also known as DIPG-DC) is an investigational cell therapy developed for patients with newly diagnosed diffuse intrinsic pontine glioma (DIPG), a rare and aggressive brain tumour that occurs mainly in children. It is a dendritic cell vaccine made from the patient's own immune cells, loaded with tumour material to help the immune system recognise and attack the cancer. PEI 15-215 has no marketing authorisation and is being studied for the first time in humans.
Key points
- PEI 15-215 is an investigational dendritic cell therapy for newly diagnosed diffuse intrinsic pontine glioma (DIPG).
- The only registered trial is a Phase 1 study with 15 participants.
- The trial is currently authorised but not yet recruiting.
- The main goal is to measure safety, specifically the number of serious adverse events.
- PEI 15-215 is given by intradermal injection as a cell suspension.
- The therapy is combined with CAR-T cells targeting IL13Ra2.
What is PEI 15-215?
PEI 15-215 is a cell therapy classified as a structurally diverse substance of cell therapy origin. Its pharmaceutical form is a cell suspension for injection, and it is given by intradermal injection. The product is also known by the name DIPG-DC, which reflects its composition: dendritic cells (DC) pulsed with lysates derived from a pool of eight DIPG K27M-positive tumour cell lines. The substance is supplied by the Fundació de Recerca Clínic Barcelona-Institut d'Investigacions Biomèdiques August Pi i Sunyer. PEI 15-215 has no marketing authorisation in the product records; it is an investigational substance.
How does PEI 15-215 work?
PEI 15-215 is a dendritic cell vaccine. Dendritic cells are immune cells that present fragments of foreign or abnormal material to other immune cells, helping to trigger an immune response. In this therapy, dendritic cells are loaded (pulsed) with lysates from DIPG tumour cell lines carrying the K27M mutation. When injected into the skin, these loaded dendritic cells are intended to stimulate the patient's T cells to recognise and attack the tumour. In the registered trial, PEI 15-215 is combined with CAR-T cells targeting IL13Ra2, a protein found on DIPG tumour cells. The CAR-T cells are derived from T cells previously stimulated by the dendritic cells, meaning the two components are designed to work together.
Which conditions is PEI 15-215 being studied for?
- Diffuse intrinsic pontine glioma (DIPG) — a rare and aggressive brain tumour that occurs mainly in children and is located in the brainstem. The registered trial focuses on patients with newly diagnosed DIPG.
How is PEI 15-215 given?
PEI 15-215 is prepared as a cell suspension for injection and is given by intradermal injection, meaning it is injected into the skin. In the registered trial, two other products are also used: DIPG-lysate, which is also given by intradermal injection, and ARI0008, the CAR-T cell product, which is given by intrathecal use (into the fluid surrounding the brain and spinal cord).
What do the clinical trials show?
There is one registered clinical trial of PEI 15-215, an early phase study in patients with newly diagnosed DIPG. The trial is a Phase 1 study, which means it is the first time the therapy is being tested in humans. Its main purpose is to evaluate safety rather than effectiveness. The trial is currently authorised but not yet recruiting participants.
The trial plans to enrol 15 patients. The primary outcome measure is the number of Grade 3–4 serious adverse events (SAEs) according to Common Toxicity Criteria (CTC) from the start of treatment until the end of the study per patient. Serious adverse events are side effects that are severe or life-threatening. The study will follow each patient from the first administration of dendritic cells through to the end of the study.
The trial investigates a combination of three products: PEI 15-215 (DIPG-DC), DIPG-lysate, and ARI0008, the CAR-T cell product targeting IL13Ra2. The study is a first-in-human administration of this combination.