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Monoclonal Antibodies

Mosunetuzumab + Polatuzumab Vedotin for Follicular Lymphoma

Phase 2

Recruiting

Led By Nancy L Bartlett, 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

Diagnosis of follicular lymphoma grade 1-3A, stage II-IV by Ann Arbor criteria

Be older than 18 years old

Must not have

Prior history of aggressive B cell lymphoma such as diffuse large B cell lymphoma or high-grade B cell lymphoma, Known history of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, Known history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH), Current or past history of CNS lymphoma, Any prior systemic therapy for follicular lymphoma, Treatment with radiotherapy within 2 weeks prior to the first dose of mosunetuzumab (otherwise one measurable lesion outside of the radiation field must remain), Treatment with any anti-CD20 monoclonal antibody within 4 weeks of Day 1 of Cycle 1, Current or recent history (within the last 6 months) of CNS disease, Treatment with systemic immunosuppressive medications, History of solid organ transplantation, History of allogeneic stem cell transplantation, Prior treatment with chimeric antigen receptor T cell therapy within 30 days before Day 1 of Cycle 1, History of severe allergic or anaphylactic reaction to humanized, chimeric, or murine monoclonal antibodies (mAbs), Known hypersensitivity to biopharmaceuticals produced in CHO cells or any component of the mosunetuzumab formulation, History of erythema multiforme, Grade ≥ 3 rash, or blistering following prior treatment with immunomodulatory derivatives, Known active bacterial, viral, fungal, or other infection, Known or suspected chronic active Epstein-Barr virus (EBV) infection, Current Grade > 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease, Active hepatitis B infection, Active hepatitis C infection, Known history of human immunodeficiency virus (HIV) positive status, History of progressive multifocal leukoencephalopathy (PML), Administration of a live, attenuated vaccine within 4 weeks before first dose of study treatment or anticipation that such a live attenuated vaccine will be required during the study, Other malignancy that could affect compliance with the protocol or interpretation of results, Active autoimmune disease requiring treatment, Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1 Day 1 or anticipation of a major surgical procedure during the course of the study, Pregnant or lactating or intending to become pregnant during the study, Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 6 years)

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial will test how well the combination of mosunetuzumab and polatuzumab vedotin works in patients with untreated follicular lymphoma.

Who is the study for?

Adults diagnosed with untreated follicular lymphoma grades 1-3A, stages II-IV. Participants must have certain symptoms or tumor sizes, be in good physical condition (ECOG ≤2), and have adequate organ function. They should not have had prior treatments for this lymphoma or other recent immunotherapies, CNS diseases, severe allergies to monoclonal antibodies, active infections like hepatitis B/C or HIV, autoimmune diseases requiring treatment, or any serious medical conditions that could interfere with the trial.

What is being tested?

The trial is testing a combination of two drugs: Mosunetuzumab and Polatuzumab vedotin on patients who haven't been treated before for follicular lymphoma. Mosunetuzumab directs immune cells to attack cancerous cells while Polatuzumab delivers a drug directly to them.

What are the potential side effects?

Potential side effects include reactions at the infusion site, fatigue, nausea, fever and chills during infusion. There may also be an increased risk of infection due to immune system suppression and possible liver enzyme changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a type of lymphoma that is not the most aggressive form.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 6 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 6 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 6 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

Number of participants with complete response (CR) as best response

Secondary study objectives

Duration of first complete response (CR)

Duration of first response of complete response (CR) or partial response (PR)

Frequencies and grades of treatment-emergent adverse events (TEAEs)

+13 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

Hypocalcaemia

Chest pain

Dyspnoea exertional

Vasospasm

Gamma-glutamyltransferase increased

Orthostatic hypotension

Cellulitis

Wound infection

Hypogammaglobulinaemia

Abdominal distension

External ear cellulitis

Tumour lysis syndrome

Upper respiratory tract infection

Back pain

Urinary tract infection

Transient ischaemic attack

Hypertension

Blood creatinine increased

Abdominal tenderness

Seasonal allergy

Injury

Hypoalbuminaemia

Epistaxis

Throat irritation

Performance status decreased

Cytomegalovirus infection reactivation

Decreased appetite

Hyperlipidaemia

Hyperglycaemia

Oropharyngeal pain

Intention tremor

Rash

Adenocarcinoma

Thrombosis

Rash maculo-papular

Squamous cell carcinoma

Photosensitivity reaction

Depression

Neutropenic sepsis

Vision blurred

Abdominal pain lower

Anal haemorrhage

Aspartate aminotransferase increased

Groin pain

Pain in jaw

100%

80%

60%

40%

20%

Study treatment Arm

Arm A: Glofit-GemOx

Arm B: Mosun-GemOx

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: Mosunetuzumab and Polatuzumab VedotinExperimental Treatment2 Interventions

Patients receive CD3xCD20 bispecific antibody mosunetuzumab administered subcutaneously in combination with CD79b directed ADC polatuzumab vedotin administered intravenously. Mosunetuzumab and polatuzumab vedotin are given in combination for 6 cycles. Mosunetuzumab is given on Days 1, 8, and 15 of cycle 1 and then Day 1 thereafter, and polatuzumab vedotin is given on Day 1. After 6 cycles, patients continue on mosunetuzumab alone for 2 additional cycles. Patients undergo scans at the end of cycle 8, and if those scans show a complete response, patients will stop any further treatment and will enter follow-up. Patients with a partial response or stable disease on scans at the end of cycle 8 may receive up to 9 additional cycles of mosunetuzumab in the absence of disease progression or unacceptable toxicity. 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 / 2Eligibility criteria met