Mosunetuzumab

Generic Name: Mosunetuzumab

Brand Names: Lunsumio

Drug Type: Biotech

CAS Number: 1905409-39-3

Unique Ingredient Identifier: LDJ89SS0YG

Background: Mosunetuzumab is a humanized anti-CD20/CD3 bispecific antibody. It can recognize and bind two different targets simultaneously, CD20 on cancer B-cells and CD3 on T-cells, allowing it to redirect T-cell cytotoxic activity to cancer cells. The standard of care for patients with B-cell lymphoma includes an anti-CD20 monoclonal antibody, such as rituximab, in combination with chemotherapy. However, patients with certain types of B-cell lymphoma, such as follicular lymphoma (FL), chronic lymphocytic leukemia (CLL) or aggressive B-cell lymphoma, have a high probability of relapse or recurrence after treatment. Mosunetuzumab has the potential to circumvent resistance to rituximab in patients with follicular lymphoma, and unlike CAR-T therapies such as axicabtagene ciloleucel and tisagenlecleucel, it is an “off-the-shelf” alternative, readily available to patients. In June 2022, the European Medicines Agency approved mosunetuzumab for the treatment of adult patients with relapsed or refractory (R/R) FL who have received at least two prior systemic therapies. In January 2023, the use of mosunetuzumab was approved by the FDA under accelerated approval based on response rate.

Indication: Mosunetuzumab as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Associated Conditions: Relapsed or Refractory Follicular Lymphoma

Clinical Trials

A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma

Phase 3

Active, not recruiting

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: Mosunetuzumab
Drug: Rituximab
Drug: Polatuzumab vedotin
Drug: Gemcitabine
Drug: Tocilizumab
Drug: Oxaliplatin

First Posted Date: 2021-12-29

Last Posted Date: 2025-05-15

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 242

Registration Number: NCT05171647

Locations: 🇺🇸
City of Hope Cancer Center, Duarte, California, United States
🇺🇸
St. Luke's Hospital, Chesterfield, Missouri, United States
🇺🇸
Ascension Seton Infusion Center, Austin, Texas, United States

and more 50 locations

Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma

Phase 2

Completed

Conditions: Non-Hodgkin Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Indolent B-Cell Non-Hodgkin Lymphoma
Marginal Zone Lymphoma
Recurrent Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue
Refractory Extranodal Marginal Zone Lymphoma of Mucosa-Associated Lymphoid Tissue

Interventions: Biological: Mosunetuzumab
Biological: Obinutuzumab
Drug: Polatuzumab Vedotin
Procedure: FDG-Positron Emission Tomography
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Bone Marrow Biopsy
Procedure: Bone Marrow Aspiration
Procedure: Biospecimen Collection

First Posted Date: 2021-12-27

Last Posted Date: 2025-04-11

Lead Sponsor: University of Washington

Target Recruit Count: 42

Registration Number: NCT05169658

Locations: 🇺🇸
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

Phase 1

Recruiting

Conditions: Non-Hodgkin Lymphoma

Interventions: Drug: SC Mosunetuzumab
Drug: IV Glofitamab
Drug: Iberdomide
Drug: Golcadomide
Drug: Obinutuzumab
Drug: Tocilizumab

First Posted Date: 2021-12-27

Last Posted Date: 2025-05-04

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 121

Registration Number: NCT05169515

Locations: 🇺🇸
UT MD Anderson Cancer Center, Houston, Texas, United States
🇮🇱
Hadassah Medical Center, Jerusalem, Israel
🇮🇱
Sourasky Medical Center, Tel-Aviv, Israel

and more 23 locations

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus

Phase 1

Completed

Conditions: Systemic Lupus Erythematosus

Interventions: Drug: Mosunetuzumab
Drug: Tocilizumab

First Posted Date: 2021-12-13

Last Posted Date: 2025-04-29

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 15

Registration Number: NCT05155345

Locations: 🇺🇸
Pinnacle Research Group, Anniston, Alabama, United States
🇲🇩
ICS ARENSIA Exploratory Medicine, Chisinau, Moldova, Republic of
🇵🇱
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy, Bydgoszcz, Poland

A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia

Phase 1

Recruiting

Conditions: Chronic Lymphocytic Leukemia

Interventions: Drug: Mosunetuzumab
Drug: Tocilizumab
Drug: Venetoclax

First Posted Date: 2021-10-25

Last Posted Date: 2025-04-27

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 137

Registration Number: NCT05091424

Locations: 🇺🇸
Mayo Clinic Rochester, Rochester, Minnesota, United States
🇺🇸
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
🇺🇸
Uni of Texas - Md Anderson Cancer Center, Houston, Texas, United States

and more 19 locations

A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7)

Phase 1

Recruiting

Conditions: B-Cell Non-Hodgkin Lymphoma
Relapsed B-Cell Non-Hodgkin Lymphoma
Refractory B-Cell Non-Hodgkin Lymphoma

Interventions: Drug: Loncastuximab Tesirine
Drug: Polatuzumab Vedotin
Drug: Glofitamab
Drug: Mosunetuzumab
Drug: Obinutuzumab

First Posted Date: 2021-07-21

Last Posted Date: 2025-05-22

Lead Sponsor: ADC Therapeutics S.A.

Target Recruit Count: 200

Registration Number: NCT04970901

Locations: 🇺🇸
Columbia University Irving Medical Center, New York, New York, United States
🇺🇸
Dana-Farber Cancer Institute, Boston, Massachusetts, United States
🇨🇿
Fakultni Nemocnice Brno, Brno, South Moravian, Czechia

and more 38 locations

CAR-T Followed by Bispecific Antibodies

Phase 2

Recruiting

Conditions: Large B-cell Lymphoma
DLBCL - Diffuse Large B Cell Lymphoma

Interventions: Drug: mosunetuzumab
Drug: glofitamab
Drug: obinutuzumab

First Posted Date: 2021-05-17

Last Posted Date: 2025-02-12

Lead Sponsor: Abramson Cancer Center at Penn Medicine

Target Recruit Count: 42

Registration Number: NCT04889716

Locations: 🇺🇸
University of Nebraska Medical Center, Omaha, Nebraska, United States
🇺🇸
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania, United States

Mosunetuzumab with Lenalidomide Augmentation As First-line Therapy for Follicular and Marginal Zone Lymphoma

Phase 2

Recruiting

Conditions: Follicular Lymphoma
Marginal Zone Lymphoma
B-cell Lymphoma

Interventions: Drug: Mosunetuzumab
Drug: Lenalidomide

First Posted Date: 2021-03-11

Last Posted Date: 2025-03-21

Lead Sponsor: Brown University

Target Recruit Count: 52

Registration Number: NCT04792502

Locations: 🇺🇸
Yale Cancer Center, New Haven, Connecticut, United States
🇺🇸
Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey, United States
🇺🇸
Lifespan Cancer Insitute, Providence, Rhode Island, United States

A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma

Phase 3

Active, not recruiting

Conditions: Relapsed or Refractory Follicular Lymphoma

Interventions: Drug: Mosunetuzumab
Drug: Lenalidomide
Drug: Rituximab
Drug: Tociluzumab

First Posted Date: 2021-01-15

Last Posted Date: 2025-04-16

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 478

Registration Number: NCT04712097

Locations: 🇧🇷
ICTR Curitiba, Curitiba, Paraná, Brazil
🇨🇳
The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China
🇫🇷
Centre Hospitalier de La Cote Basque, Bayonne, France

and more 110 locations

A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma

Phase 1

Completed

Conditions: B-cell Lymphoma

Interventions: Drug: Gemcitabine
Drug: Glofitamab
Drug: Oxaliplatin
Drug: Mosunetuzumab
Drug: Obinutuzumab
Drug: Tocilizumab

First Posted Date: 2020-03-18

Last Posted Date: 2024-03-25

Lead Sponsor: Hoffmann-La Roche

Target Recruit Count: 23

Registration Number: NCT04313608

Locations: 🇦🇺
Prince of Wales Hospital; Haematology, Randwick, New South Wales, Australia
🇦🇺
Monash Health Monash Medical Centre, Clayton, Victoria, Australia
🇦🇺
St Vincent's Hospital Melbourne, Fitzroy, Victoria, Australia

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