Clinical trial · Interventional
A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma
A Phase Ib/II, Open-Label, Multicenter, Randomized, Controlled Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-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, pharmacokinetics, and preliminary efficacy of mosunetuzumab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (M-CHOP) and, subsequently, in combination with cyclophosphamide, doxorubicin, and prednisone (CHP) plus polatuzumab vedotin (CHP-pola) in participants with relapsed or refractory (R/R) B-cell non-Hodgkin lymphoma (NHL), and in previously untreated participants with diffuse large B-cell lymphoma (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 (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Mosunetuzumab | Drug | Mosunetuzumab | ALIAS |
| Polatuzumab Vedotin | Drug | Polatuzumab Vedotin | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Rituxumab | Drug | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Phase Ib: Mosunetuzumab (M)-CHOP Dose Finding
- description
- Participants will receive M-CHOP up to the phase II recommended dose (RP2D).
- interventionNames
- Drug: Mosunetuzumab
- Drug: Polatuzumab Vedotin
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Vincristine
- Drug: Prednisone
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Phase Ib: M-CHP-Pola Dose-Finding
- description
- Participants will receive M-CHP-Pola up to the RP2D.
- interventionNames
- Drug: Mosunetuzumab
- Drug: Polatuzumab Vedotin
- Drug: Cyclophosphamide
- Drug: Doxorubicin
- Drug: Prednisone
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria for Phase Ib and Phase II Portions * 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 * Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2 * Adequate hematologic function Inclusion Criteria for Phase Ib Portion Participants must also meet the following criteria for study entry into the Phase Ib portion: * Histologically confirmed B-cell NHL according to the World Health Organization (WHO) 2016 classification expected to express the cluster of differentiation-20 (CD20) antigen * Relapsed or refractory (R/R) B-cell NHL after at least one prior systemic lymphoma therapy * Treatment with at least one prior CD20-directed therapy * Group B only: no prior treatment with polatuzumab vedotin Inclusion Criteria for Phase II Portion Participants must also meet the following criteria for study entry in the Phase II portion: * Previously untreated, histologically confirmed DLBCL according to WHO 2016 classification * International Prognostic Index (IPI) score of 2-5 Exclusion Criteria * Prior treatment with mosunetuzumab * Prior allogenic stem-cell transplant * Current Grade \>1 peripheral neuropathy * Participants with 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) * Prior solid organ transplantation * History of autoimmune disease * Current or past history of central nervous system (CNS) lymphoma * Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease * Significant cardiovascular disease or pulmonary disease * Clinically significant history of liver disease * Recent major surgery within 4 weeks before the start of C1D1, other than superficial lymph node biopsies for diagnosis Exclusion Criteria for Phase Ib Portion Participants who also meet any of the following criteria will be excluded from study entry in the Phase Ib portion: * Prior treatment with chemotherapy, immunotherapy, and biologic therapy 4 weeks prior to C1D1 * Prior treatment with radiotherapy within 2 weeks prior to C1D1 * Adverse events from prior anti-cancer therapy resolved to ≤Grade 1 (with the exception of alopecia and anorexia) * Prior treatment with \>250 mg/m\^2 doxorubicin (or equivalent anthracycline dose) Exclusion Criteria for Phase II Portion Participants who also meet any of the following criteria will be excluded from study entry in the Phase II portion: * Participants with transformed lymphoma * Prior therapy for B-cell NHL
References
Publications (2)
- DERIVEDWestin J, Phillips TJ, Mehta A, Hoffmann MS, Gonzalez-Barca E, Thieblemont C, Bastos-Oreiro M, Greil R, Giebel S, Wei MC, Wang J, Bucher R, Sit J, Penuel E, Purev E, Yee DL, Bergua-Burgues JM. Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a phase 2 study. Blood Adv. 2025 May 27;9(10):2461-2472. doi: 10.1182/bloodadvances.2024014907. PMID 39908481
- DERIVEDOlszewski AJ, Phillips TJ, Hoffmann MS, Armand P, Kim TM, Yoon DH, Mehta A, Greil R, Westin J, Lossos IS, Munoz JL, Sit J, Wei MC, Yang A, Chen V, Purev E, Yee DL, Jaeger U. Mosunetuzumab in combination with CHOP in previously untreated DLBCL: safety and efficacy results from a phase 2 study. Blood Adv. 2023 Oct 24;7(20):6055-6065. doi: 10.1182/bloodadvances.2023010840. PMID 37581593