A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies (NCT05207670)

🧪 Interventions in This Study

• Mosunetuzumab (Cohorts A-C) (DRUG)
• Mosunetuzumab (Cohorts D-E) (DRUG)
• Tocilizumab (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. At least one bi-dimensionally measurable nodal lesion, defined as \>1.5 cm in its longest dimension, or one bi-dimensionally measurable lesion, defined as \>1.0 cm in its longest diameter by computed tomography (CT) scan, positivie emission tomography - computed tomography (PET- CT), or magnetic resonance imaging (MRI)
2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
3. Adequate hematologic function
4. No active infection
5. Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on antiretroviral therapy for at least 4 weeks, have a CD4 count ≥ 200/µL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months
6. For women of childbearing potential (except those in Cohort B): agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating eggs, as defined by the protocol
7. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined by the protocol Inclusion Criteria Specific to Cohorts A1 and A2
8. Previously untreated FL with indication to start systemic therapy
9. Adequate renal function Inclusion Criteria Specific to Cohort B
10. Aged ≥ 80 years at the time of signing informed consent form (ICF), or aged 65-79 years and considered ineligible for chemoimmunotherapy (R-CHOP) with at least one of the following: Impairment in ≥ 2 Activities of Daily Living (ADL); impairment in ≥ 2 Instrumental Activities of Daily Living (IADL); or Cumulative Illness Rating Scale-Geriatric (CIRS-G) score of ≥ 1 comorbidity with a severity of 3-4 or a score of 2 in ≥ 8 comorbidities
11. Histologically confirmed DLBCL according to WHO 2016 classification expected to express the CD20 antigen (Swerdlow et al. 2016)
12. Previously untreated DLBCL with indication to start systemic therapy and are not eligible for curative therapy

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

• Infirmary Cancer Care — Mobile, Alabama
• Alaska Oncology & Hematology, LLC — Anchorage, Alaska
• Mayo Clinic Arizona — Phoenix, Arizona
• City of Hope — Duarte, California
• Rocky Mountain Cancer Centers (Aurora) - USOR — Aurora, Colorado
• Medical Oncology Hematology Consultants — Newark, Delaware
• SCRI Florida Cancer Specialists South — Fort Myers, Florida
• Mayo Clinic Jacksonville - PPDS — Jacksonville, Florida
• Cancer Specialists of North Florida - Jacksonville — Jacksonville, Florida
• Florida Cancer Specialists - NORTH - SCRI - PPDS — St. Petersburg, Florida
• Florida Cancer Specialists - EAST - SCRI - PPDS — West Palm Beach, Florida
• Mission Blood and Cancer - MercyOne Cancer Center — Des Moines, Iowa
• University of Kansas Medical Center — Westwood, Kansas
• Oncology Hematology Care - SCRI — Zachary, Louisiana
• American Oncology Partners of Maryland, PA — Bethesda, Maryland
• Mayo Clinic - PPDS — Rochester, Minnesota
• St. Vincent Frontier Cancer Center — Billings, Montana
• Astera Cancer Care East Brunswick — East Brunswick, New Jersey
• San Juan Oncology Associates — Farmington, New Mexico
• New York Oncology Hematology, P.C. — Albany, New York
• New York Cancer & Blood Specialists - New Hyde Park — New Hyde Park, New York
• NY Cancer & Blood Specialist — New York, New York
• North Shore Hematology Oncology Association PC — Shirley, New York
• New York Cancer & Blood Specialists - Bronx — The Bronx, New York
• Oncology Hematology Care Inc - Cincinnati - USOR — Cincinnati, Ohio

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Review the official NIH record below to find the coordinating site.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.