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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 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

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

Rhinorrhoea

Stomatitis

Pneumonia

Blood creatinine increased

Hyponatraemia

Paraesthesia

Muscle spasms

Epistaxis

Infusion related reaction

Dysuria

Chest pain

Tachycardia

Infection

Neck pain

Hypoaesthesia

Febrile neutropenia

Hypoalbuminaemia

Hypophosphataemia

Dry skin

Pain in extremity

Dry mouth

Haemorrhoids

Asthenia

Chills

Oral candidiasis

Hiccups

Dry eye

Pruritus

Pain

Weight decreased

Arthralgia

Acute kidney injury

Thrombocytopenia

Dysphagia

Upper respiratory tract infection

Decreased appetite

Tremor

Hypokalaemia

Pollakiuria

Rash maculo-papular

Hyperuricaemia

Depression

Hypertension

Large intestinal haemorrhage

Abdominal pain

Septic shock

Haematuria

Superficial vein thrombosis

Activated partial thromboplastin time prolonged

Vascular access complication

Non-cardiac chest pain

Hyperphosphataemia

Lymphopenia

Urinary tract infection

Oropharyngeal pain

100%

80%

60%

40%

20%

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

0 / 15Eligibility criteria met