BO43243 Mosunetuzmab in Relapsed/Refractory Chronic Lymphocytic Leukaemia
Research type
Research Study
Full title
A PHASE IB OPEN-LABEL, MULTICENTER STUDY EVALUATING THE SAFETY, EFFICACY, AND PHARMACOKINETICS OF MOSUNETUZUMAB IN PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
IRAS ID
1003988
Contact name
Micaela Rocco
Contact email
Sponsor organisation
F. Hoffmann-La Roche Ltd
Eudract number
2021-000846-16
Research summary
The purpose of this study is to assess the safety and effectiveness of a new drug, mosunetuzumab to address a significant unmet medical need in patients with relapsed/refractory chronic lymphocytic leukaemia (CLL).
Mosunetuzumab will be tested at different doses to find out if it is safe and to understand the way the drug is processed by the body.
Mosunetuzumab is an experimental drug, which means health authorities have not approved it for the treatment of CLL.While approvals of some new treatments have improved outcomes for patients with relapsed/refractory CLL, the only potentially curative strategy for CLL is a stem cell transplantation for which the majority of patients with CLL are not eligible. Therefore, developing improved treatment options is critically important for this population. Because relapsed/refractory CLL represents a poorly treated and incurable disease for the majority of patients, there exists a need to introduce new agents that may improve clinical outcomes.
This study will test different doses of mosunetuzumab in cohorts (groups) of about 3 patients. Each dose will be given as a subcutaneous (under the skin) injection. After each dose patients will be asked to remain in the hospital for 2 days, during which time they will also be given a corticosteroid to minimize potential side effects.
The dose of mosunetuzumab will increase every week until the target dose is reached, unless the participants cancer worsens or they have unacceptable side effects. Once the target dose is reached, mosunetuzumab will be given once every 21 days, until approximately 12 months have passed (17 visits). Hospitalization will no longer be required once target dose has been reached.The study will last approximately 4 years in the UK. There will be approximately 6 patients recruited at 3 UK sites. 56 patients are expected to take part worldwide.
The study is sponsored by F. Hoffman La Roche, Research Summary; Version Number 1.0, 25 Jun 2021
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0245
Date of REC Opinion
17 Sep 2021
REC opinion
Favourable Opinion