2023-506986-74-00Active, not recruitingPhase 1/2
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
An Open-Label, Multicenter, Phase Ib/II Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination with Polatuzumab Vedotin in Patients with B-Cell Non-Hodgkin Lymphoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 Jul 2026
Brief summary (registry, in English)
Phase Ib To evaluate the safety and tolerability of mosunetuzumab (Mosun) + polatuzumab vedotin (Pola) in patients with relapsed or refractory (R/R) DLBCL or follicular lymphoma (FL), including estimation of maximum tolerated dose, determination of recommended Phase II dose (RP2D), characterization of dose-limiting toxicity (DLT) To make a preliminary assessment of the anti-tumor activity of Mosun + Pola Phase II: To evaluate the efficacy of Mosun (IV) plus Pola in patients with R/R FL and R/R DLBCL, based on best objective response rate (ORR) in the study, as determined by the Independent Review Committee (IRC) To evaluate the efficacy of Mosun (SC) plus Pola in patients with R/R DLBCL and R/R MCL based on best ORR in the study, as determined by the Independent Review Committee (IRC)
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- First submitted
- 7 Nov 2023
- Start date
- 27 Dec 2021
- Lead sponsor
- F. Hoffmann-La Roche AG
- Diseases
- Hodgkin lymphoma
- EU CT number
- 2023-506986-74-00
- EudraCT number
- 2018-001141-13
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 17
- 8 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment
- Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola
- Prior use of any monoclonal antibodies, radioimmunoconjugates or antibody-drug conjugates for anti-lymphoma treatment within 4 weeks before first dose of study treatment
- Prior treatment with Mosun or other CD20-directed bispecific antibodies or with Pola
Other illness
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
- Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
Other
- 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
- Pregnant or lactating women
- Current > Grade 1 peripheral neuropathy
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Brussel | Jette | Belgium | Active, not recruiting |
| Pôle Hospitalier Jolimont | La Louvière | Belgium | Active, not recruiting |
| Clinique Saint Pierre | Ottignies-Louvain-la-Neuve | Belgium | Active, not recruiting |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Active, not recruiting |
| Institut Catala D'oncologia | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario Infanta Leonor | Madrid | Spain | Active, not recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Active, not recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.