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
Key facts
- Where
- Cáceres, L'Hospitalet de Llobregat, Madrid és Sevilla, SpanyolországSee the 5 sites
- Phase
- 1/2. fázis
Where in Spanyolország
- Hospital San Pedro De AlcántaraCáceres, SpanyolországNo longer taking part
- Institut Catala D'oncologiaL'Hospitalet de Llobregat, SpanyolországNo longer taking part
- Hospital General Universitario Gregorio MarañónMadrid, SpanyolországNo longer taking part
- Hospital Universitario Infanta LeonorMadrid, SpanyolországNo longer taking part
- Hospital Universitario Virgen De La MacarenaSevilla, SpanyolországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- F. Hoffmann-La Roche AG
- Trial code
- EU 2023-506986-74-00
- Record updated
- 2026. július 14.
- Original description
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)Read full original descriptionShow less
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
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)
Inclusion: 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.
Exclusion: 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; 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; 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.