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Monoclonal Antibodies

Mosunetuzumab for Marginal Zone Lymphoma

Phase 2
Waitlist Available
Research Sponsored by Izidore Lossos, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men and women aged 18 years or older at the time of signing informed consent
Histologically confirmed EMZL presenting with stage I-IV disease
Must not have
Evidence of diffuse large B cell lymphoma (DLBCL) transformation
Patients that need immediate cytoreduction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new medication called Mosunetuzumab to see if it can help people with a type of lymphoma called Extranodal Marginal Zone Lymphoma (EMZ

Who is the study for?
This trial is for individuals with a type of cancer called Extranodal Marginal Zone Lymphoma (EMZL), who haven't been treated yet. It's open to those whose cancer ranges from stage I-IV, indicating various extents of disease spread.
What is being tested?
The study is testing Mosunetuzumab, a new medication, to see if it can help treat EMZL effectively. The goal is to determine whether this drug improves patient outcomes and its safety profile.
What are the potential side effects?
While the specific side effects for Mosunetuzumab in this trial are not listed, similar medications often cause reactions like fatigue, infusion-related symptoms, low blood counts, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer is EMZL and has been confirmed through tissue examination.
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I am willing to provide a tissue sample for testing.
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I can care for myself and am up and about more than 50% of my waking hours.
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I have not received any treatment for my condition.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My lymphoma has changed into a more aggressive form known as DLBCL.
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I need immediate treatment to reduce my cancer cells.
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I am currently receiving or have received cancer treatment.
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I am HIV positive.
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I have had an organ transplant.
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I have had brain lymphoma or cancer spread to the lining of my brain and spinal cord.
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I am experiencing symptoms of graft versus host disease.
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I have or might have a long-term active Epstein-Barr virus infection.
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I have or might have had HLH.
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I have an active hepatitis B infection.
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I haven't taken any immune-weakening medications in the last 2 weeks.
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I do not have any uncontrolled serious health conditions.
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I have serious heart or lung disease.
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I have not had any other cancer in the last 3 years.
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I have an active hepatitis C infection.
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I have had a stem cell transplant or CAR T-cell therapy.
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I have never had progressive multifocal leukoencephalopathy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Complete Response (CR) Rate
Secondary study objectives
Duration of Response (DOR)
Number of Participants Experiencing Cytokine Release Syndrome Adverse Events
Number of Participants Experiencing treatment-related adverse events
+5 more

Side effects data

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

Awards & Highlights

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: Mosunetuzumab Treatment GroupExperimental Treatment1 Intervention
Participants in this group will receive Mosunetuzumab for eight (8) 21-day cycles. Total participation is about 3.5 years.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140

Find a Location

Who is running the clinical trial?

Izidore Lossos, MDLead Sponsor
Genentech, Inc.Industry Sponsor
1,560 Previous Clinical Trials
569,419 Total Patients Enrolled
1 Trials studying MALT Lymphoma
26 Patients Enrolled for MALT Lymphoma
~23 spots leftby Dec 2030
Unbiased ResultsWe believe in providing patients with all the options.
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