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Mosunetuzumab

Generic Name
Mosunetuzumab
Brand Names
Lunsumio
Drug Type
Biotech
Chemical Formula
-
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
Associated Therapies
-

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

Phase 3
Recruiting
Conditions
Classic Follicular Lymphoma
Follicular Lymphoma With Unusual Cytological Features
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Biological: Mosunetuzumab
Biological: Rituximab
Biological: Rituximab and Hyaluronidase Human
First Posted Date
2024-03-29
Last Posted Date
2025-01-03
Lead Sponsor
National Cancer Institute (NCI)
Target Recruit Count
600
Registration Number
NCT06337318
Locations
🇺🇸

Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States

🇺🇸

Cedars Sinai Medical Center, Los Angeles, California, United States

🇺🇸

Helen F Graham Cancer Center, Newark, Delaware, United States

and more 94 locations

Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma

Phase 1
Recruiting
Conditions
Large B-cell Lymphoma
High-grade B-cell Lymphoma
Transformed B-Cell Lymphoma
Follicular Lymphoma Grade 3B
Interventions
Drug: Mosunetuzumab
Drug: DHAX
Drug: ICE
First Posted Date
2022-07-19
Last Posted Date
2024-12-30
Lead Sponsor
Washington University School of Medicine
Target Recruit Count
24
Registration Number
NCT05464329
Locations
🇺🇸

Washington University School of Medicine, Saint Louis, Missouri, United States

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
First Posted Date
2021-10-25
Last Posted Date
2024-12-30
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
137
Registration Number
NCT05091424
Locations
🇺🇸

Memorial Sloan-Kettering Cancer Center, New York, New York, United States

🇺🇸

Uni of Texas - Md Anderson Cancer Center, Houston, Texas, United States

🇦🇺

Princess Alexandra Hospital Woolloongabba, Woolloongabba, Queensland, Australia

and more 19 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
2025-01-03
Lead Sponsor
Hoffmann-La Roche
Target Recruit Count
188
Registration Number
NCT03677154
Locations
🇮🇱

Hadassah Ein-Karem, Jerusalem, Israel

🇰🇷

The Catholic University of Korea Yeouido St. Mary's Hospital, Seoul, Korea, Republic of

🇵🇱

Szpital Wojewodzki w Opolu, Opole, Poland

and more 28 locations
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