← Back to Search

Monoclonal Antibodies

Mosunetuzumab + Polatuzumab for Non-Hodgkin Lymphoma

Phase 1 & 2

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG PS of 0, 1, or 2

Histologically confirmed FL, DLBCL, or MCL

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)

Awards & highlights

Study Summary

This trial will study the safety and effectiveness of two drugs, mosunetuzumab and polatuzumab vedotin, given together intravenously or subcutaneously, in people with various types of non-Hodgkin lymphoma who have relapsed or are refractory to at least two prior lines of systemic therapy.

Who is the study for?

This trial is for adults with certain types of B-cell non-Hodgkin lymphoma who have tried at least one prior treatment. Specifically, it's for those with relapsed or refractory diffuse large B-cell, follicular, or mantle cell lymphoma. Participants should be in a stable enough condition to perform daily activities (ECOG PS 0-2) and must not have had recent CAR-T therapy, stem cell transplants, or certain other treatments.Check my eligibility

What is being tested?

The study tests Mosunetuzumab given via IV or SC injection combined with Polatuzumab Vedotin. It starts by finding the right doses and then expands to treat more patients. The goal is to see how safe and effective this combo is for second-line treatment of relapsed/refractory B-cell non-Hodgkin lymphomas.See study design

What are the potential side effects?

Possible side effects include reactions at the injection site, increased risk of infections due to immune system suppression, fatigue, nausea, fever from infusion reactions (like chills), potential liver issues indicated by blood test changes, and nerve damage symptoms like numbness.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can take care of myself and perform daily activities.

Select...

My cancer is either follicular lymphoma, diffuse large B-cell lymphoma, or mantle cell lymphoma.

Select...

I have had treatment with an anti-CD20 therapy for my lymphoma.

Select...

I have had at least two treatments for my MCL, including anti-CD20 therapy, a BTK inhibitor, and either anthracycline or bendamustine.

Select...

I have a tumor that can be measured and is larger than 1.5 cm if it's in a lymph node or larger than 1.0 cm if it's outside of lymph nodes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to approximately 60 months (assessed at screening and then every 3 months for the first year, then every 6 months until disease progression, start of new anti-cancer therapy, or withdrawal) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Objective Response Rate (ORR), Defined as CR or Partial Response (PR) at any Time, Based on PET-CT and/or CT Scan, as Determined by the Independent Review Committee (IRC) using Standard Criteria for NHL

Maximum Tolerated Dose (MTD) of Mosunetuzumab in Combination with Polatuzumab Vedotin

Percentage of Participants with Adverse Events (AE)

+1 more

Secondary outcome measures

ADAs to Polatuzumab Vedotin

Anti-Drug Antibodies (ADAs) to Mosunetuzumab

Best CR Rate on Study Based on PET-CT, and/or CT Scan, as Determined by the Investigator and IRC Using Standard Criteria for NHL

+8 more

Trial Design

5Treatment groups

Experimental Treatment

Group I: Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCLExperimental Treatment3 Interventions

Participants with at least 2 lines of prior therapy (3L+) will receive subcutaneous (SC) mosunetuzumab + polatuzumab vedotin.

Group II: Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCLExperimental Treatment3 Interventions

2L+ participants with R/R DLBCL will receive SC mosunetuzumab and polatuzumab vedotin.

Group III: Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCLExperimental Treatment4 Interventions

2L+ participants with R/R diffuse large B-cell lymphoma will receive mosunetuzumab + polatuzumab vedotin.

Group IV: Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FLExperimental Treatment3 Interventions

Participants with at least one line of prior therapy (2L+) and that have relapsed or refractory (R/R) follicular lymphoma (FL) will receive mosunetuzumab + polatuzumab vedotin.

Group V: Dose FindingExperimental Treatment3 Interventions

Participants will receive mosunetuzumab in combination with polatuzumab vedotin. Dose finding will be guided by the observed incidence of dose-limiting toxicities (DLTs) at each dose level.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rituximab

1999

Completed Phase 4

~1880

Tocilizumab

2012

Completed Phase 4

~1840

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,088,632 Total Patients Enrolled

Clinical TrialsStudy DirectorHoffmann-La Roche

2,199 Previous Clinical Trials

888,080 Total Patients Enrolled

Media Library

Mosunetuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03671018 — Phase 1 & 2

Non-Hodgkin's Lymphoma Research Study Groups: Dose Finding, Mosunetuzumab + Polatuzumab Vedotin 2L+R/R DLBCL, Mosunetuzumab SC + Polatuzumab Vedotin 2L+R/R DLBCL, Mosunetuzumab + Polatuzumab Vedotin 2L+ R/R FL, Mosunetuzumab SC + Polatuzumab Vedotin 3L+R/R MCL

Non-Hodgkin's Lymphoma Clinical Trial 2023: Mosunetuzumab Highlights & Side Effects. Trial Name: NCT03671018 — Phase 1 & 2

Mosunetuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03671018 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the geographic scope of this clinical experiment?

"Currently, this medical trial is available in 20 diverse locations including Tampa, New york and Birmingham. It might be prudent for participants to choose the site nearest them to reduce travel costs if they decide to take part."

Answered by AI

Is enrollment for this investigation open at present?

"The clinical trial is currently enrolling volunteers. This information, available on clinicaltrials.gov, reflects the original posting date of September 25th 2018 and last update of November 10th 2022."

Answered by AI

How many participants are currently participating in this clinical trial?

"Affirmative, the investigation is actively looking for participants as evident from clinicaltrials.gov's records. Launched on September 25th 2018 and most recently updated on November 10th 2022, this study requires 422 patients distributed amongst 20 different medical centres."

Answered by AI

Have any other research projects utilized the intravenous version of Mosunetuzumab?

"Mosunetuzumab (IV) was initially studied in 2012 at Svendborg Hospital OUH. Thus far, 638 trials have been concluded while 90 active studies are currently underway; notably many of these experiments are centred around Tampa, Florida."

Answered by AI

What pathologies has Mosunetuzumab (IV) been clinically validated to address?

"Mosunetuzumab (IV) is frequently prescribed to patients undergoing therapeutic procedure. It has also been noted in clinical studies that this medication can be beneficial for those with diffuse large b-cell lymphoma, systemic juvenile idiopathic arthritis and cytokine release syndrome caused by car-t cell therapy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma

2018. "A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03671018.

All > Rhode Island