FIH Phase 1/2, Dose Escalation Study of BOXR1030 T cells in Advanced GPC3-Positive Solid Tumours
Research type
Research Study
Full title
A First-in-Human, Phase 1/2, Dose Escalation Study of BOXR1030 T cells in Subjects With Advanced GPC3-Positive Solid Tumors.
IRAS ID
1005273
Contact name
Glen Weiss
Contact email
Sponsor organisation
SOTIO Biotech Inc
Eudract number
2021-005086-41
ISRCTN Number
ISRCTN15110275
Clinicaltrials.gov Identifier
Research summary
This study is to test the safety of giving BOXR1030 to participants with cancer expressing GPC3.It will test BOXR1030, referred to as a chimeric antigen receptor (CAR) T cell therapy, a type of cellular therapy made up of immune cells that normally fight infection. BOXR1030 is made using white blood cells (WBCs), which are removed from participants peripheral blood.The WBCs are sent to a manufacturing facility, where they will be grown outside of the body with ingredients added to help expand T cells.While they grow a retrovirus will be used to introduce genetic material into the cells which will become a permanent part of the participants T cells’ genetic material and creates a new protein on the cells.This protein on the outside surface of the participants T cells, a so-called T cell receptor (TCR), is designed to recognise GPC3 expressed on tumour cells.A second protein will be produced within the participants cells (GOT2) to enhance fitness of these T cells to combat cancer.BOXR1030 is infused back into participants once manufacturing is complete.The BOXR1030 T cells can then target and attack tumour tissues that express GPC3. It's thought that as healthy cells do not express GPC3, BOXR1030 T cells will selectively recognise the tumour cells.To increase the chance of the participants body accepting BOXR1030, participants will receive 2 chemotherapy medicines approved by the MHRA, called fludarabine and cyclophosphamide which are not intended to treat cancer directly but may transiently impact the immune system to help BOXR1030 work. This study has 2 parts. The 1st part is the dose escalation phase.The 2nd part is the expansion phase. Participants will be in either the first or second part.Up to 20 study sites in the US, UK and the EU will enrol about 98 participants.The study is expected to run for approximately 24 months, participants will continue in long term follow up for up to 15 years after BOXR1030 administration; assessments will be performed throughout
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0096
Date of REC Opinion
2 Aug 2022
REC opinion
Further Information Favourable Opinion