MedPath

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

Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial

Phase 2
Not yet recruiting
Conditions
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Recurrent Follicular Lymphoma
Refractory Follicular Lymphoma
Interventions
Procedure: Biospecimen Collection
Procedure: Biopsy Procedure
Procedure: Computed Tomography
Procedure: Positron Emission Tomography
Procedure: Bone Marrow Aspiration
Procedure: Bone Marrow Biopsy
Other: Questionnaire Administration
First Posted Date
2025-04-29
Last Posted Date
2025-04-29
Lead Sponsor
University of Washington
Target Recruit Count
22
Registration Number
NCT06948786
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

CHOP Plus Mosunetuzumab as First Line in Patients With Richter´s Syndrome: a Phase II Study of the Spanish Group of CLL

Phase 2
Recruiting
Conditions
Richter Syndrome
Interventions
First Posted Date
2025-04-13
Last Posted Date
2025-04-13
Lead Sponsor
GELLC (Grupo Español de Leucemia Linfocítica Crónica)
Target Recruit Count
34
Registration Number
NCT06926205
Locations
🇪🇸

Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain

🇪🇸

H Marqués de Valdecilla, Santander, Cantabria, Spain

🇪🇸

Hospital Universitario Virgen del Rocío, Sevilla, Spain

and more 13 locations

A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP

Phase 2
Not yet recruiting
Conditions
Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
First Posted Date
2025-02-17
Last Posted Date
2025-05-06
Lead Sponsor
Danielle Wallace
Target Recruit Count
40
Registration Number
NCT06828991
Locations
🇺🇸

Wilmot Cancer Institute, Rochester, New York, United States

A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies

Phase 1
Recruiting
Conditions
B-cell Malignancy
Relapsed Cancer
Refractory Cancer
B-cell Lymphoma
Interventions
First Posted Date
2024-10-10
Last Posted Date
2025-05-09
Lead Sponsor
BeiGene
Target Recruit Count
80
Registration Number
NCT06634589
Locations
🇮🇹

Centroricerche Cliniche Di Verona Srl, Verona, Italy

🇺🇸

Mayo Clinic Phoenix, Phoenix, Arizona, United States

🇺🇸

University of Southern Californianorris Comprehensive, Los Angeles, California, United States

and more 42 locations

Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

Phase 2
Not yet recruiting
Conditions
Diffuse Large B Cell Lymphoma (DLBCL)
Interventions
First Posted Date
2024-09-19
Last Posted Date
2025-02-18
Lead Sponsor
Medical College of Wisconsin
Target Recruit Count
31
Registration Number
NCT06594939
Locations
🇺🇸

Froedtert Hospital & the Medical College of Wisconsin, Milwaukee, Wisconsin, United States

Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma

Phase 2
Recruiting
Conditions
Extranodal Marginal Zone Lymphoma
Interventions
First Posted Date
2024-08-26
Last Posted Date
2024-11-25
Lead Sponsor
Izidore Lossos, MD
Target Recruit Count
35
Registration Number
NCT06569680
Locations
🇺🇸

University of Miami, Miami, Florida, United States

A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma

Phase 2
Recruiting
Conditions
Lymphoma
Interventions
First Posted Date
2024-08-20
Last Posted Date
2025-03-10
Lead Sponsor
M.D. Anderson Cancer Center
Target Recruit Count
36
Registration Number
NCT06563505
Locations
🇺🇸

MD Anderson Cancer Center, Houston, Texas, United States

Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients

Phase 2
Not yet recruiting
Conditions
Follicular Lymphoma
Interventions
First Posted Date
2024-07-09
Last Posted Date
2024-07-12
Lead Sponsor
Fondazione Italiana Linfomi - ETS
Target Recruit Count
56
Registration Number
NCT06492837
Locations
🇮🇹

ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia, Milano, Italy

🇮🇹

IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia, Bari, Italy

🇮🇹

A.O.U. Città della Salute e della Scienza di Torino, S.C.Ematologia, Torino, Italy

and more 17 locations

Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma

Phase 2
Recruiting
Conditions
Refractory Grade 3a Follicular Lymphoma
Refractory Grade 1 Follicular Lymphoma
Refractory Grade 2 Follicular Lymphoma
Recurrent Grade 1 Follicular Lymphoma
Recurrent Grade 3a Follicular Lymphoma
Recurrent Grade 2 Follicular Lymphoma
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
First Posted Date
2024-06-11
Last Posted Date
2024-08-15
Lead Sponsor
City of Hope Medical Center
Target Recruit Count
41
Registration Number
NCT06453044
Locations
🇺🇸

City of Hope Medical Center, Duarte, California, United States

🇺🇸

City of Hope Orange County Lennar Foundation Cancer Center, Irvine, California, United States

Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma

Phase 2
Recruiting
Conditions
Ann Arbor Stage II Follicular Lymphoma
Grade 2 Follicular Lymphoma
Ann Arbor Stage IV Follicular Lymphoma
Ann Arbor Stage II Marginal Zone Lymphoma
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage IV Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Ann Arbor Stage III Marginal Zone Lymphoma
Interventions
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Procedure: Positron Emission Tomography
Other: Questionnaire Administration
First Posted Date
2024-06-04
Last Posted Date
2025-02-27
Lead Sponsor
University of Washington
Target Recruit Count
20
Registration Number
NCT06442475
Locations
🇺🇸

Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, United States

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