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Mosunetuzumab for Aggressive B-Cell Lymphoma

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 3 years post-autosct (estimated to be 3 years and 7 weeks).
Awards & highlights

Study 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.

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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 2021 Phase 1 trial • 23 Patients • NCT04313608
41%
Cytokine release syndrome
35%
Diarrhoea
35%
Hypomagnesaemia
35%
Pyrexia
35%
Neuropathy peripheral
35%
Anaemia
24%
Thrombocytopenia
24%
Hypophosphataemia
24%
Liver function test abnormal
24%
Nausea
24%
Neutropenia
24%
Fatigue
24%
Constipation
24%
Platelet count decreased
18%
Headache
18%
Sepsis
18%
Neutrophil count decreased
18%
Arthralgia
18%
Peripheral sensory neuropathy
18%
Hypokalaemia
18%
Oral candidiasis
18%
Weight decreased
18%
Lethargy
12%
Flushing
12%
Superficial vein thrombosis
12%
Paraesthesia
12%
Blood alkaline phosphatase increased
12%
Abdominal pain
12%
Dizziness
12%
Abdominal discomfort
12%
Colitis
12%
Vomiting
12%
Rectal haemorrhage
12%
Gastrooesophageal reflux disease
12%
Pain in extremity
12%
Infusion related reaction
12%
Alanine aminotransferase increased
12%
Cough
6%
Cytomegalovirus infection reactivation
6%
Rash
6%
Thrombosis
6%
Upper respiratory tract infection
6%
Rash maculo-papular
6%
Pain in jaw
6%
Orthostatic hypotension
6%
Squamous cell carcinoma
6%
Vision blurred
6%
Abdominal distension
6%
Abdominal tenderness
6%
Tumour lysis syndrome
6%
Back pain
6%
Hypocalcaemia
6%
Hypertension
6%
Cellulitis
6%
Neutropenic sepsis
6%
Transient ischaemic attack
6%
Chest pain
6%
Aspartate aminotransferase increased
6%
Blood creatinine increased
6%
Adenocarcinoma
6%
Oropharyngeal pain
6%
Groin pain
6%
Abdominal pain lower
6%
Anal haemorrhage
6%
Performance status decreased
6%
Hypogammaglobulinaemia
6%
Seasonal allergy
6%
Urinary tract infection
6%
Gamma-glutamyltransferase increased
6%
Hyperlipidaemia
6%
External ear cellulitis
6%
Decreased appetite
6%
Hyperglycaemia
6%
Epistaxis
6%
Depression
6%
Photosensitivity reaction
6%
Injury
6%
Wound infection
6%
Hypoalbuminaemia
6%
Dyspnoea exertional
6%
Intention tremor
6%
Throat irritation
6%
Vasospasm
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A: Glofit-GemOx
Arm B: Mosun-GemOx

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

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
568,097 Total Patients Enrolled
Washington University School of MedicineLead Sponsor
1,949 Previous Clinical Trials
2,307,581 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
~10 spots leftby Jul 2027