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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

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

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.

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.

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).

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

Thrombosis

Rash

Rash maculo-papular

Upper respiratory tract infection

Cytomegalovirus infection reactivation

Pain in jaw

Orthostatic hypotension

Squamous cell carcinoma

Vision blurred

Abdominal distension

Abdominal tenderness

Tumour lysis syndrome

Back pain

Hypocalcaemia

Hypertension

Cellulitis

Neutropenic sepsis

Transient ischaemic attack

Chest pain

Aspartate aminotransferase increased

Blood creatinine increased

Adenocarcinoma

Oropharyngeal pain

Groin pain

Abdominal pain lower

Anal haemorrhage

Performance status decreased

Hypogammaglobulinaemia

Seasonal allergy

Urinary tract infection

Gamma-glutamyltransferase increased

Hyperlipidaemia

External ear cellulitis

Decreased appetite

Hyperglycaemia

Epistaxis

Depression

Photosensitivity reaction

Injury

Wound infection

Hypoalbuminaemia

Dyspnoea exertional

Intention tremor

Throat irritation

Vasospasm

100%

80%

60%

40%

20%

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

0 / 15Eligibility criteria met