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Monoclonal Antibodies

Mosunetuzumab for Follicular Lymphoma

Phase 2
Recruiting
Led By Lorenzo Falchi, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 years or older
Adequate hepatic function
Must not have
Prior solid organ transplantation
Acute or chronic HCV infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Summary

This trial is testing mosunetuzumab, a drug that helps the immune system fight cancer, in people newly diagnosed with follicular lymphoma.

Who is the study for?
Adults with newly diagnosed, untreated Follicular Lymphoma (FL) grades 1, 2, or 3A are eligible for this trial. They must have measurable disease and be fit for chemoimmunotherapy. Key requirements include good liver and bone marrow function, no severe heart or lung conditions, no active infections or other cancers within the last two years. Participants need to agree to biopsies and use effective contraception if of childbearing potential.
What is being tested?
The study is testing Mosunetuzumab's effectiveness in treating Follicular Lymphoma that hasn't been treated before. It aims to determine whether this drug can help patients with FL by assessing its impact on their cancer.
What are the potential side effects?
While not explicitly listed in the provided information, similar drugs often cause side effects like infusion reactions (fever/chills), fatigue, weakness, nausea/vomiting/diarrhea; low blood cell counts leading to increased infection risk; possible allergic reactions.

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 liver is working well.
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My cancer is at an advanced stage but not the earliest or final stages.
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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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My bone marrow is working well.
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My diagnosis is untreated Follicular Lymphoma of grade 1, 2, or 3A.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a solid organ transplant.
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I have hepatitis C.
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I have or had lymphoma in my brain or spinal cord.
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I have had a stem cell transplant from a donor.
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I have been diagnosed with PML in the past.
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I have or had a serious brain or spinal cord disease.
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I am currently taking medication that weakens my immune system.
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My condition is either Follicular Lymphoma grade 3B or transformed Follicular Lymphoma.
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I do not have any serious medical conditions or abnormal lab test results.
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I have received treatment for lymphoma before.
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I have a serious heart condition.
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I have had cancer before.
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I have or might have had HLH in the past.
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I have not received any live vaccines recently.
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I currently have an active infection.
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I have a serious lung condition.
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My follicular lymphoma is only in one area outside of the lymph nodes.
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I am not eligible for systemic therapy.
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I have an ongoing Epstein-Barr Virus infection.

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
Rate of Complete Respons/CR
Secondary study objectives
Overall Response Rate/ORR

Side effects data

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

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Agent MosunetuzumabExperimental Treatment1 Intervention
Participants with newly diagnosed FL in need of systemic therapy
Group II: Mosunetuzumab + ZanubrutinibExperimental Treatment2 Interventions
Participants with newly diagnosed FL in need of systemic therapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mosunetuzumab
2019
Completed Phase 2
~140
Zanubrutinib
2017
Completed Phase 3
~1940

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,956 Previous Clinical Trials
595,480 Total Patients Enrolled
Lorenzo Falchi, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

Media Library

Mosunetuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05389293 — Phase 2
Follicular Lymphoma Research Study Groups: Single Agent Mosunetuzumab, Mosunetuzumab + Zanubrutinib
Follicular Lymphoma Clinical Trial 2023: Mosunetuzumab Highlights & Side Effects. Trial Name: NCT05389293 — Phase 2
Mosunetuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05389293 — Phase 2
~25 spots leftby Dec 2025
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