Clinical trial · Interventional
Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Participants With Diffuse Large B-Cell Lymphoma Following First-Line Immunochemotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Participants With Previously Untreated Diffuse Large B-Cell Lymphoma
A Phase I/II Trial of Mosunetuzumab (BTCT4465A) as Consolidation Therapy in Patients With Diffuse Large B-Cell Lymphoma Following First-Line Immunotherapy and as Monotherapy or in Combination With Polatuzumab Vedotin in Elderly/Unfit Patients With Previously Untreated Diffuse Large B-Cell 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, pharmacokinetics, and preliminary efficacy of mosunetuzumab following first-line diffuse large B-cell lymphoma (DLBCL) immunochemotherapy in participants with a best response of stable disease or partial response, or in elderly/unfit participants with previously untreated DLBCL, or subcutaneous mosunetuzumab in combination with polatuzumab vedotin IV in elderly/unfit participants with previously untreated 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 |
|---|---|---|---|
| Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mosunetuzumab Intravenous (IV) | Drug | Mosunetuzumab | ALIAS |
| Mosunetuzumab Subcutaneous (SC) | Drug | Mosunetuzumab | ALIAS |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Consolidation Therapy (Cohort A)
- description
- Participants with a partial response to first-line chemotherapy will receive mosunetuzumab up to the recommended consolidation dose (RCD).
- interventionNames
- Drug: Mosunetuzumab Intravenous (IV)
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Elderly/Unfit Previously Untreated Monotherapy (Cohort B)
- description
- Elderly/unfit participants with previously untreated DLBCL will receive mosunetuzumab at the previously determined recommended phase II dose (RP2D).
- interventionNames
- Drug: Mosunetuzumab Intravenous (IV)
- Drug: Tocilizumab
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for All Cohorts * At least one bi-dimensionally measurable nodal lesion, defined as \> 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as \> 1.0 cm in its longest diameter * Adequate hematologic function * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2; with the exception of South Korea, where participants 80 years or older with ECOG \>/= 2 will not be eligible Inclusion Criteria Specific to Cohort A Participants in Cohort A must also meet the following criteria for study entry: * Histologically confirmed DLBCL according to World Health Organization (WHO) 2016 expected to express the cluster of differentiation-20 (CD20) antigen * One prior therapy with any systemic anthracycline-based chemoimmunotherapy containing regimen for previously untreated DLBCL * Best response of SD or PR to prior systemic chemoimmunotherapy at the end of induction treatment in accordance with the Lugano 2014 criteria Inclusion Criteria Specific to Cohorts B and C Participants in Cohorts B and C must also meet the following criteria for study entry: * Previously untreated, histologically confirmed, DLBCL according to WHO 2016 classification * Age \>/= 80 years, or * Age 65-79 years and considered ineligible for chemoimmuotherapy (R-CHOP) with at least one of the following: Impairment in at least two activity of daily living (ADL) components as defined in the protocol; impairment in at least two instrumental ADL components as defined in the protocol; cumulative illness rating scale - geriactic (CIRS-G) score of at least one cormorbidity with a severity score of 3-4 (not including lymphoma and hematologic deficiencies due to lymphoma) or a score of 2 in \>/= 8 comorbidities; impairment in cardiac function, renal function, liver function, or other comorbidities such that the participant is unfit for full-dose immunochemotherapy, such as rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) * Participants with an initial ECOG performance status of 3 may be considered during screening if the performance status is DLBCL-related and if pre-phase treatment during the screening phase (not more than 100 mg/day up to 7 days prior to Cycle 1 Day 1) results in an improvement of ECOG performance status to \</= 2 prior to enrollment Exclusion Criteria for All Cohorts Participants who meet any of the following criteria will be excluded from study entry: * Transformed lymphoma * CNS lymphoma * Prior treatment with mosunetuzumab * Prior stem cell transplant (autologous and allogeneic) * History of confirmed progressive multifocal leukoencephalopathy (PML) * Known or suspected chronic active Epstein Barr virus (CAEBV), hepatitis B, hepatitis C (HCV), or Human Immunodeficiency Virus (HIV) * Known or suspected history of hemophagocytic lymphohistiocytosis (HLH) * Positive SARS-CoV-2 antigen or PCR test within 30 days prior to Cycle 1 Day 1 * Prior solid organ transplantation * Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Clinically significant history of liver disease * Prior treatment with radiotherapy within 2 weeks prior to Cycle 1, Day 1 (C1D1) * Significant cardiovascular disease Exclusion Criteria Specific to Cohort A Participants in Cohort A who meet the following criteria will be excluded from study entry: \- Prior anti-lymphoma treatment with chemotherapy, immunotherapy, or biologic therapy 4 weeks prior to C1D1 Exclusion Criterion Specific to Cohorts B and C Participants in Cohorts B and C who meet the following criterion will be excluded from study entry: \- Prior treatment for DLBCL with chemotherapy, immunotherapy, and biologic therapy Exclusion Criteria Specific to Cohort C Participants in Cohort C who meet the following criteria will be excluded from study entry: \- Current Grade \>1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
References
Publications (1)
- DERIVEDDuell J, Westin J. The future of immunotherapy for diffuse large B-cell lymphoma. Int J Cancer. 2025 Jan 15;156(2):251-261. doi: 10.1002/ijc.35156. Epub 2024 Sep 25. PMID 39319495