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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 โ€œoff-the-shelfโ€ 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

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma

Phase 1
Recruiting
Conditions
Follicular Lymphoma
Interventions
First Posted Date
2020-01-29
Last Posted Date
2025-05-02
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
237
Registration Number
NCT04246086
Locations
๐Ÿ‡จ๐Ÿ‡ณ

West China Hospital, Sichuan University, Chengdu, China

๐Ÿ‡ซ๐Ÿ‡ท

CHRU de Lille - Hopital Claude Huriez, Lille, France

๐Ÿ‡ซ๐Ÿ‡ท

CHU Montpellier, Montpellier, France

and more 20 locations

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

Phase 1
Active, not recruiting
Conditions
Diffuse Large B-cell Lymphoma
Interventions
First Posted Date
2018-09-19
Last Posted Date
2025-04-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
188
Registration Number
NCT03677154
Locations
๐Ÿ‡ฎ๐Ÿ‡ฑ

Rambam Medical Center, Haifa, Israel

๐Ÿ‡ฎ๐Ÿ‡ฑ

Carmel medical center, Haifa, Israel

๐Ÿ‡ฐ๐Ÿ‡ท

Severance Hospital, Yonsei University, Seoul, Korea, Republic of

and more 24 locations

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

First Posted Date
2018-09-19
Last Posted Date
2024-12-18
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
117
Registration Number
NCT03677141
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Alabama Birmingham, Birmingham, Alabama, United States

๐Ÿ‡บ๐Ÿ‡ธ

Banner MD Anderson Cancer Center, Gilbert, Arizona, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of California; Moores Cancer Center, La Jolla, California, United States

and more 38 locations

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

Phase 1
Active, not recruiting
Conditions
B-cell Non-Hodgkin Lymphoma
Interventions
First Posted Date
2018-09-14
Last Posted Date
2024-11-28
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
422
Registration Number
NCT03671018
Locations
๐Ÿ‡บ๐Ÿ‡ธ

University of Pittsburgh - Hillman Cancer Center, Pittsburgh, Pennsylvania, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Miami Miller School of Medicine, Miami, Florida, United States

๐Ÿ‡บ๐Ÿ‡ธ

University of Texas M.D. Anderson Cancer Center, Houston, Texas, United States

and more 26 locations
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