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Mosunetuzumab for Aggressive B-Cell Lymphoma
Saint Louis, MO
Phase 1
Recruiting
Led By Armin Ghobadi, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adequate hematologic function: Absolute neutrophil count ≥ 1,000/mcL without G-CSF use in past 7 days, Platelets ≥ 75,000/mcL without TPO mimetic use in past 7 days, Hemoglobin ≥ 8 g/dL without red blood cell transfusion in past 7 days
Diagnosis of rCD20+ diffuse large B cell lymphoma, high-grade B cell lymphoma, transformed B cell lymphoma, or follicular lymphoma grade 3B
Must not have
History of progressive multifocal leukoencephalopathy (PML)
Prior allogeneic stem cell transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years post-autosct (estimated to be 3 years and 7 weeks).
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Summary
This trial is testing mosunetuzumab as a treatment for aggressive B cell lymphomas. Mosunetuzumab is an antibody that targets T cells and cancerous B cells. The goal is to use mosunetuzumab to direct T cells to kill cancerous B cells.
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Who is the study for?
Adults with aggressive B cell lymphomas who are planning to undergo autologous stem cell transplant. They must have adequate organ function, no recent major infections or vaccinations, and not be pregnant. Men and women must agree to use effective contraception during the study and for 3 months after the last dose of mosunetuzumab.Check my eligibility
What is being tested?
The trial is testing mosunetuzumab as a consolidation therapy post-autologous stem cell transplant in patients with relapsed or refractory aggressive B cell lymphomas. Mosunetuzumab is an engineered antibody designed to direct T cells to kill cancerous B cells.See study design
What are the potential side effects?
Potential side effects include reactions related to immune system activation such as inflammation in various organs, infusion-related reactions, increased risk of infection, and possibly others that are currently unknown due to the investigational nature of mosunetuzumab.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood counts meet the required levels without recent medical help.
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I have been diagnosed with a specific type of aggressive lymphoma.
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I can take care of myself and am up and about more than half of my waking hours.
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I plan to have a stem cell transplant for my lymphoma after at least two previous treatments.
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I am 18 years old or older.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had progressive multifocal leukoencephalopathy in the past.
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I have had a stem cell transplant from a donor.
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I have a history of MAS or HLH.
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I am HIV positive.
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I have or might have a long-term active Epstein-Barr virus infection.
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I have had a solid organ transplant.
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I have an active hepatitis B or C infection.
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My lymphoma did not respond to chemotherapy before my stem cell transplant.
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I have had severe side effects from previous immune therapy.
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I have a significant history of liver disease.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 3 years post-autosct (estimated to be 3 years and 7 weeks).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 3 years post-autosct (estimated to be 3 years and 7 weeks).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Frequencies and grades of treatment-emergent adverse events (TEAEs)
Percentage of consented and enrolled patients completing at least 2 cycles of mosunetuzumab consolidation
Rate of treatment discontinuation due to treatment-emergent adverse events (TEAEs)
Secondary study objectives
Number of tocilizumab doses per patient for management of cytokine release syndrome (CRS)
Overall survival (OS)
Percentage of patients requiring any tocilizumab doses for management of cytokine release syndrome (CRS)
+1 moreSide effects data
From 2023 Phase 1 & 2 trial • 117 Patients • NCT0367714167%
Anaemia
67%
Thrombocytopenia
67%
Diarrhoea
67%
Oedema peripheral
67%
Fall
67%
Platelet count decreased
67%
Decreased appetite
67%
Hypomagnesaemia
67%
Neuropathy peripheral
33%
Supraventricular tachycardia
33%
Sepsis
33%
Dry skin
33%
Pneumocystis jirovecii pneumonia
33%
Malignant neoplasm progression
33%
Hypotension
33%
Neutropenia
33%
Abdominal pain
33%
Nausea
33%
Oral pain
33%
Stomatitis
33%
Vomiting
33%
Fatigue
33%
Influenza
33%
Weight decreased
33%
White blood cell count decreased
33%
Hypokalaemia
33%
Hyponatraemia
33%
Taste disorder
33%
Confusional state
33%
Acute kidney injury
33%
Cough
33%
Hiccups
33%
Alopecia
33%
Nail disorder
33%
Rash
33%
Urticaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group A1: Phase Ib Mosunetuzumab + CHOP
Group A2: Phase Ib Mosunetuzumab + CHOP
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Group C: Phase II Mosunetuzumab + CHOP
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Consolidation MosunetuzumabExperimental Treatment1 Intervention
Mosunetuzumab is a CD3xCD20 bispecific antibody administered intravenously in the consolidation setting after autologous stem cell transplant (autoSCT). Mosunetuzumab will be given in a step-up dosing schedule beginning on Day 49 after autoSCT on C1D1, C1D8, C1D15, and then Day 1 of all cycles thereafter. Patients will undergo PET-CT restaging around Day 100 post-autoSCT (approximately Cycle 3) and patients in complete response will continue mosunetuzumab for up to 17 cycles in the absence of disease progression or unacceptable toxicity. Patients not in complete response will discontinue treatment and enter follow-up. All cycles are planned to be 21 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
FDA approved
Find a Location
Closest Location:Washington University School of Medicine· Saint Louis, MO
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,576 Previous Clinical Trials
570,952 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
2,022 Previous Clinical Trials
2,351,479 Total Patients Enrolled
Armin Ghobadi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
109 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I don't have any other cancer that could interfere with this study.My blood counts meet the required levels without recent medical help.I have been diagnosed with a specific type of aggressive lymphoma.I have had progressive multifocal leukoencephalopathy in the past.I do not have any major health issues that could interfere with the study.My lymphoma has spread to my bone marrow, but I meet specific health criteria.I have had a stem cell transplant from a donor.I can take care of myself and am up and about more than half of my waking hours.I have a history of MAS or HLH.I plan to have a stem cell transplant for my lymphoma after at least two previous treatments.I am HIV positive.I have or might have a long-term active Epstein-Barr virus infection.I have had a solid organ transplant.I have an active hepatitis B or C infection.My lymphoma did not respond to chemotherapy before my stem cell transplant.I have had severe side effects from previous immune therapy.I have not had any significant brain diseases or issues in the last 6 months.I am 18 years old or older.I have a significant history of liver disease.
Research Study Groups:
This trial has the following groups:- Group 1: Consolidation Mosunetuzumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.