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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~at 3 years post-autosct (estimated to be 3 years and 7 weeks).
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years post-autosct (estimated to be 3 years and 7 weeks). for reporting.

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 more

Side effects data

From 2023 Phase 1 & 2 trial • 117 Patients • NCT03677141
45%
Fatigue
41%
Nausea
41%
Alopecia
32%
Neutropenia
32%
Headache
27%
Insomnia
23%
Anaemia
23%
Vomiting
23%
Neutrophil count decreased
18%
Alanine aminotransferase increased
18%
Diarrhoea
18%
Peripheral sensory neuropathy
18%
Rash
18%
Constipation
18%
Neuropathy peripheral
14%
Hyperglycaemia
14%
Platelet count decreased
14%
Aspartate aminotransferase increased
14%
Dyspnoea
14%
Lymphocyte count decreased
14%
Cough
14%
International normalised ratio increased
14%
White blood cell count decreased
14%
Back pain
14%
Blood alkaline phosphatase increased
14%
Myalgia
9%
Rhinorrhoea
9%
Stomatitis
9%
Pneumonia
9%
Blood creatinine increased
9%
Hyponatraemia
9%
Paraesthesia
9%
Muscle spasms
9%
Epistaxis
9%
Infusion related reaction
9%
Dysuria
9%
Chest pain
9%
Tachycardia
5%
Infection
5%
Neck pain
5%
Hypoaesthesia
5%
Febrile neutropenia
5%
Hypoalbuminaemia
5%
Hypophosphataemia
5%
Dry skin
5%
Pain in extremity
5%
Dry mouth
5%
Haemorrhoids
5%
Asthenia
5%
Chills
5%
Oral candidiasis
5%
Hiccups
5%
Dry eye
5%
Pruritus
5%
Pain
5%
Weight decreased
5%
Arthralgia
5%
Acute kidney injury
5%
Thrombocytopenia
5%
Dysphagia
5%
Upper respiratory tract infection
5%
Decreased appetite
5%
Tremor
5%
Hypokalaemia
5%
Pollakiuria
5%
Rash maculo-papular
5%
Hyperuricaemia
5%
Depression
5%
Hypertension
5%
Large intestinal haemorrhage
5%
Abdominal pain
5%
Septic shock
5%
Haematuria
5%
Superficial vein thrombosis
5%
Activated partial thromboplastin time prolonged
5%
Vascular access complication
5%
Non-cardiac chest pain
5%
Hyperphosphataemia
5%
Lymphopenia
5%
Urinary tract infection
5%
Oropharyngeal pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: Phase II Rituximab + CHP-Pola (Randomized)
Arm 1: Phase II Mosunetuzumab + CHP-Pola (Randomized)
Group B: Phase Ib Mosunetuzumab + CHP-Pola
Group C: Phase II Mosunetuzumab + CHOP
Group A1: Phase Ib Mosunetuzumab + CHOP
Group A2: Phase Ib Mosunetuzumab + CHOP

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
2,351,478 Total Patients Enrolled
Armin Ghobadi, M.D.Principal InvestigatorWashington University School of Medicine
5 Previous Clinical Trials
109 Total Patients Enrolled

Media Library

Mosunetuzumab Clinical Trial Eligibility Overview. Trial Name: NCT05412290 — Phase 1
B-Cell Lymphoma Research Study Groups: Consolidation Mosunetuzumab
B-Cell Lymphoma Clinical Trial 2023: Mosunetuzumab Highlights & Side Effects. Trial Name: NCT05412290 — Phase 1
Mosunetuzumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT05412290 — Phase 1
~8 spots leftby Jul 2027