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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
EU CTIS ID: 2023-506986-74-00
What this study is testing
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)
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- United States
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.