LEU01101: Safety and preliminary efficacy of LEU011 in solid tumours.
Research type
Research Study
Full title
A Phase I/IIa open-label dose escalation trial evaluating the safety and preliminary efficacy of LEU011 in subjects with relapsed/refractory solid tumours.
IRAS ID
1007679
Contact name
Róisín Beehag
Contact email
Sponsor organisation
Leucid Bio
Clinicaltrials.gov Identifier
Research summary
Solid tumours make up around 90% of human cancers. More than 80% of these cancers have specific proteins, known as NKG2D ligands, on their surface. Our immune system can naturally detect these proteins, but in people with advanced cancer, this system is overwhelmed. Leucid has developed a treatment called LEU011 that targets these proteins aiming to help the immune system attack the cancer cells.
LEU011 is a type of treatment called CAR T-cell therapy, which is made from the patient’s own blood. Doctors take white blood cells called T-cells from the patient’s blood and modify them with a harmless virus to create two new proteins. One protein helps the T-cells find tumours in the body, while the other, called a CAR (chimeric antigen receptor), lets the T-cells attach to the cancer cells and attack them. The hope is that LEU011 will find and destroy tumour cells in the patient.
This clinical trial will test if LEU011 is a safe treatment for patients with solid tumours that have NKG2D ligands and have either returned after treatment or have not responded to treatment.
To take part in the study, patients must have a certain type of solid tumour that hasn’t responded well to previous treatments. Participants will first receive chemotherapy to lower their existing immune cells, making room for the LEU011 treatment to grow in their body. Then, LEU011 will be given into patients’ veins over about 30 minutes. The dose of LEU011 given will vary depending on when the patient joins the study.
Some participants will receive a radioactive marker that attaches to LEU011 in the body and can be seen on special scans. This will help researchers understand how LEU011 travels in the body, finds tumours, and whether the therapy can be improved.
The main goal of this study is to see how well LEU011 is tolerated in humans, what side effects it might cause, and to determine the best dose for future studies.
REC name
North East - York Research Ethics Committee
REC reference
23/NE/0097
Date of REC Opinion
14 Aug 2023
REC opinion
Further Information Favourable Opinion