PORTAL
Research type
Research Study
Full title
A phase II trial of polatuzumab vedotin, obinutuzumab and glofitamab as a peri-CAR-T cell treatment strategy in large B-cell lymphoma
IRAS ID
1007177
Contact name
Nick McNally
Contact email
Sponsor organisation
University College London
Eudract number
2022-003727-17
Clinicaltrials.gov Identifier
Research summary
The study will test a new combination of 3 drugs (glofitamab (glofit), polatuzumab vedotin (pola) and obinutuzumab (obin)) in patients with large B-cell lymphoma (LBCL), which has come back or not responded to previous treatment. It will test how safe and effective this drug combination is at treating LBCL before and after CAR-T therapy.
CAR-T cell therapy is a new, effective treatment for LCBL. “Bridging” therapy is given to stabilise patients while waiting for the CAR-T cells to be made. There is a need to improve bridging therapy options with new non-chemotherapy drugs, to reduce the tumour burden before CAR-T therapy, for maximum benefit. Over half of LBCL patients progress after CAR-T therapy and there is also an unmet need for rapid access to post-CAR-T therapies.
Glofit is a new antibody therapy that stimulates the body’s immune system to attack cancer cells. Pola is an antibody therapy with a chemotherapy drug attached to it. The antibody delivers the chemotherapy drug to the cancer to destroy the cancer cells. Obin is an antibody treatment given as a safety measure to reduce the side effects of glofit.
The trial is divided into 2 parts:
Part 1: patients whose LBCL has progressed/not responded to previous treatment and are due to start standard CAR-T therapy. All patients receive 2 cycles of glofit and pola. Obin is given on cycle 1 day 1. Patients have a PET-CT scan to check the response. If the scan shows a response, patients will receive CAR-T therapy. If not, patients receive 4 more cycles of glofit and pola, and then 6 cycles of glofit.
Part 2: patients whose LBCL has progressed/not responded after standard CAR-T cell therapy. All patients receive 6 cycles of glofit and pola, and then 6 cycles of glofit. Obin is given on cycle 1 day 1.The study is funded by F.Hoffman-La Roche Ltd and will recruit 84-99 patients from 10-15 UK hospitals. Patients will be followed up until the last patient completes their 1-year post-treatment follow up.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
24/SW/0024
Date of REC Opinion
18 Mar 2024
REC opinion
Further Information Favourable Opinion