Clinical trial · Interventional
A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma
An Open-Label, Randomized, 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
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of intravenous (IV) or subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin in participants with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL). It will consist of a dose finding portion followed by an expansion phase for second line or later (2L+) participants with relapsed or refractory (R/R) DLBCL and 2L+ R/R FL. In addition, subcutaneous mosunetuzumab in combination with polatuzumab vedotin will be evaluated in participants with at least 2 prior lines of systemic therapy (3L+) for the treatment of R/R mantle cell lymphoma (MCL) and in participants with 2L+ R/R DLBCL.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B-cell Non-Hodgkin Lymphoma | B-Cell Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mosunetuzumab (IV) | Drug | Mosunetuzumab | ALIAS |
| Mosunetuzumab (SC) | Drug | Mosunetuzumab | ALIAS |
| Polatuzumab vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Rituximab | Drug | Rituximab | ALIAS |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Dose Finding
- description
- Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.
- interventionNames
- Drug: Mosunetuzumab (IV)
- Drug: Polatuzumab vedotin
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL
- description
- Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.
- interventionNames
- Drug: Mosunetuzumab (IV)
- Drug: Polatuzumab vedotin
- Drug: Tocilizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * ECOG PS of 0, 1, or 2 * Histologically confirmed FL, DLBCL, or MCL * Must have received at least one prior systemic treatment regimen containing an anti-CD20-directed therapy for DLBCL or FL * For MCL, participants must have received at least two prior systemic treatment regiments, which include 1) anti-CD20-directed therapy, 2) BTK inhibitor, and 3) anthracycline or bendamustine * Relapsed to prior regimen(s) after having a documented history of response (complete response \[CR\], CR unconfirmed \[CRu\], or partial response \[PR\]) of \>/= 6 months in duration from completion of regimen(s); or, refractory to any prior regimen, defined as no response to the prior therapy, or progression within 6 months of completion of the last dose of therapy * 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 * Adequate hematologic, renal, and hepatic function Key Exclusion Criteria: * Prior treatment with mosunetuzumab or other CD20-directed bispecific antibodies * Prior treatment with polatuzumab vedotin * Current \> Grade 1 peripheral neuropathy * Prior use of any monoclonal antibody, radioimmunoconjugate or antibody-drug conjugate (ADC) within 4 weeks before first dose of study treatment * Treatment with any chemotherapeutic agent, or treatment with any other anti-cancer agent (investigational or otherwise) within 4 weeks or 5 half-lives of the drug, whichever is shorter, prior to first dose of study treatment * Treatment with radiotherapy within 2 weeks prior to the first dose of study treatment * Autologous stem-cell transplantation (SCT) within 100 days prior to first study treatment administration * Prior treatment with chimeric antigen receptor T-cell (CAR-T) therapy within 30 days before first study treatment administration * Prior allogeneic SCT * Prior solid organ transplantation * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Patients with history of confirmed progressive multifocal leukoencephalopathy (PML) * Current or past history of central nervous system (CNS) lymphoma or CNS disease * History of autoimmune disease
References
Publications (1)
- Source
- PubMed (NLM)
- Dataset
- PubMed E-utilities
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
Julio C Chavez, Mariana Bastos-Oreiro, Catherine Diefenbach et al. · Am J Hematol · Sep 1, 2026 · PMID 42283231 pubmed
- DERIVEDChavez JC, Bastos-Oreiro M, Diefenbach C, Lossos IS, Shah N, Assouline S, Olszewski AJ, Naik S, Ghosh N, Pham S, Wei MC, Batlevi C, To I, Ead W, Makadia S, Penuel E, Jing J, Budde LE. A Randomized Phase II Study of Subcutaneous Mosunetuzumab in Combination With Polatuzumab Vedotin Compared With Rituximab Plus Polatuzumab Vedotin in Patients With Relapsed or Refractory Large B-Cell Lymphoma. Am J Hematol. 2026 Sep;101(9):2177-2189. doi: 10.1002/ajh.70403. Epub 2026 Jun 12. PMID 42283231
- DERIVEDBudde LE, Kamdar M, Assouline SE, Chavez JC, Ghosh N, Ollila TA, Hodson DJ, Modi D, Bastos-Oreiro M, Naik SG, Nakhoda SK, Lee Batlevi C, Wang J, Makadia S, Kwan A, Penuel E, Jing J, Wu H, Ead W, Pham S, To I, Wei MC, Wang ML. Mosunetuzumab plus polatuzumab vedotin for relapsed/refractory MCL after BTK inhibitor therapy: a phase 2 study. Blood. 2026 Aug 6;148(6):682-692. doi: 10.1182/blood.2025032422.