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
Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
- Conditions
- Classic Follicular LymphomaFollicular Lymphoma With Unusual Cytological Features
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Positron Emission Tomography
- First Posted Date
- 2024-03-29
- Last Posted Date
- 2025-05-20
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 600
- Registration Number
- NCT06337318
- Locations
- 🇺🇸
University of Alabama at Birmingham Cancer Center, Birmingham, Alabama, United States
🇺🇸Mayo Clinic Hospital in Arizona, Phoenix, Arizona, United States
🇺🇸University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5
- Conditions
- Follicular Lymphoma
- Interventions
- First Posted Date
- 2024-02-28
- Last Posted Date
- 2024-10-11
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Target Recruit Count
- 790
- Registration Number
- NCT06284122
- Locations
- 🇫🇷
HOPITAL HENRI MONDOR - Unité Hémopathies Lymphoïdes, Créteil, France
🇫🇷GUSTAVE ROUSSY CANCER CAMPUS GRAND PARIS - Département Médecine Oncologique, Villejuif, France
🇫🇷CH ANNECY GENEVOIS - SITE D'ANNECY - Service Hématologie, Pringy, France
Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma
- Conditions
- High Grade B-Cell LymphomaDiffuse Large B-Cell Lymphoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Bone Marrow Aspiration and BiopsyProcedure: Computed TomographyProcedure: EchocardiographyProcedure: Magnetic Resonance ImagingProcedure: Multigated Acquisition ScanProcedure: Positron Emission Tomography
- First Posted Date
- 2024-02-08
- Last Posted Date
- 2025-03-24
- Lead Sponsor
- OHSU Knight Cancer Institute
- Target Recruit Count
- 30
- Registration Number
- NCT06249191
- Locations
- 🇺🇸
OHSU Knight Cancer Institute, Portland, Oregon, United States
Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- High Grade B-Cell LymphomaDiffuse Large B-Cell Lymphoma, Not Otherwise SpecifiedTransformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
- Interventions
- Procedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Positron Emission Tomography
- First Posted Date
- 2023-08-29
- Last Posted Date
- 2025-03-11
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 30
- Registration Number
- NCT06015880
- Locations
- 🇺🇸
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
🇺🇸City of Hope Comprehensive Cancer Center LAO, Duarte, California, United States
🇺🇸City of Hope Comprehensive Cancer Center, Duarte, California, United States
Mosunetuzumab-Lenalidomide Versus Investigator Choices in Patients With Relapsed or Refractory Marginal Zone Lymphoma
- Conditions
- Marginal Zone Lymphoma
- Interventions
- Drug: - Rituximab + Lenalidomide (28-days cyclesDrug: - Rituximab + Bendamustine (28-days cycles)Drug: - Rituximab + CHOP (21-days cycles)
- First Posted Date
- 2023-08-23
- Last Posted Date
- 2025-01-27
- Lead Sponsor
- The Lymphoma Academic Research Organisation
- Target Recruit Count
- 260
- Registration Number
- NCT06006117
- Locations
- 🇧🇪
INSTITUT JULES BORDET - Service Hématologie, Anderlecht, Belgium
🇧🇪UNIVERSITE CATHOLIQUE DE LOUVAIN SAINT-LUC - Service Hématologie, Brussels, Belgium
🇧🇪UNIVERSITAIR ZIEKENHUIS GENT - Service Hématologie, Gent, Belgium
Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma
- Conditions
- Follicular Lymphoma
- Interventions
- First Posted Date
- 2023-08-16
- Last Posted Date
- 2025-04-09
- Lead Sponsor
- Weill Medical College of Cornell University
- Target Recruit Count
- 50
- Registration Number
- NCT05994235
- Locations
- 🇺🇸
Weill Cornell Medicine/NewYork-Presbyterian Hospital, New York, New York, United States
A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia
- Conditions
- Refractory B-cell Acute Lymphoblastic Leukemia
- Interventions
- First Posted Date
- 2023-07-27
- Last Posted Date
- 2023-10-10
- Lead Sponsor
- M.D. Anderson Cancer Center
- Registration Number
- NCT05961696
- Locations
- 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States
Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma
- Conditions
- Nodular Lymphocyte Predominant B-Cell LymphomaRecurrent Nodular Lymphocyte Predominant B-Cell LymphomaRefractory Nodular Lymphocyte Predominant B-Cell Lymphoma
- Interventions
- Procedure: Biopsy ProcedureProcedure: Biospecimen CollectionProcedure: Bone Marrow BiopsyProcedure: Computed TomographyOther: Fludeoxyglucose F-18Procedure: Positron Emission Tomography
- First Posted Date
- 2023-06-02
- Last Posted Date
- 2025-05-22
- Lead Sponsor
- National Cancer Institute (NCI)
- Target Recruit Count
- 70
- Registration Number
- NCT05886036
- Locations
- 🇺🇸
City of Hope Comprehensive Cancer Center, Duarte, California, United States
🇺🇸UM Sylvester Comprehensive Cancer Center at Aventura, Aventura, Florida, United States
🇺🇸UM Sylvester Comprehensive Cancer Center at Coral Gables, Coral Gables, Florida, United States
Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries
- First Posted Date
- 2023-05-09
- Last Posted Date
- 2023-11-01
- Lead Sponsor
- Oslo University Hospital
- Target Recruit Count
- 80
- Registration Number
- NCT05849857
- Locations
- 🇳🇴
Oslo University Hospital, Oslo, Norway
🇫🇮Helsinki University Hospital, Helsinki, Finland
🇳🇴St. Olavs hospital, Trondheim, Norway
Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma
- Conditions
- Recurrent Diffuse Large B-Cell LymphomaRecurrent Grade 3b Follicular LymphomaRecurrent Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell LymphomaRecurrent High Grade B-Cell LymphomaRecurrent Primary Mediastinal (Thymic) Large B-Cell LymphomaRecurrent Transformed Chronic Lymphocytic LeukemiaRefractory Grade 3b Follicular LymphomaRefractory Diffuse Large B-Cell LymphomaRefractory Primary Mediastinal (Thymic) Large B-Cell LymphomaRefractory Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma
- Interventions
- Procedure: BiopsyProcedure: Biospecimen CollectionProcedure: Computed TomographyProcedure: Positron Emission Tomography
- First Posted Date
- 2023-01-05
- Last Posted Date
- 2025-02-06
- Lead Sponsor
- City of Hope Medical Center
- Target Recruit Count
- 36
- Registration Number
- NCT05672251
- Locations
- 🇺🇸
City of Hope Medical Center, Duarte, California, United States
Drug Development Updates
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