A Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma
- Conditions
- B-cell non-Hodgkin lymphoma (NHL)MedDRA version: 21.1Level: LLTClassification code: 10023769Term: Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10012856Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent Class: 10029104MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10023768Term: Large cell immunoblastic lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10012857Term: Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory Class: 10029104MedDRA version: 21.0Level: LLTClassification code: 10012820Term: Diffuse large B-cell lymphoma NOS Class: 10029104MedDRA version: 21.1Level: LLTClassification code: 10067070Term: Follicular B-cell non-Hodgkin's lymphoma Class: 10029104Therapeutic area: Diseases [C] - Hemic and Lymphatic Diseases [C15]Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506986-74-00
- Lead Sponsor
- F. Hoffmann-La Roche AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 235
Age = 18 years at time of signing Informed Consent Form, Patients must have histologically confirmed R/R FL, DLBCL, or MCL, For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy, For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine, Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension., Patients must have histologically confirmed R/R FL, DLBCL, or MCL, For DLBCL or FL, must have received at least one prior systemic treatment regimen containing an anti- cluster of differentiation 20 (CD20) - directed therapy, For MCL, must have received at least two prior systemic treatment regimens which include agents from all three classes below: anti-CD20-directed therapy, a Bruton’s tyrosine kinase (BTK) inhibitor, and an anthracycline or bendamustine, Age = 18 years at time of signing Informed Consent Form, Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2, Measurable disease, defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension.
Current eligibility for autologous SCT in patients with R/R DLBCL, R/R transformed FL, or R/R Grade 3b FL, Current > Grade 1 peripheral neuropathy, Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment, Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease, Pregnant or lactating women, Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola, Current > Grade 1 peripheral neuropathy, Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment, Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease, Current eligibility for autologous SCT in patients with R/R DLBCL, R/R transformed FL, or R/R Grade 3b FL, Pregnant or lactating women, Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method