← Back to Search

Monoclonal Antibodies

Mosunetuzumab for Non-Hodgkin's Lymphoma (MorningSun Trial)

Phase 2
Recruiting
Research Sponsored by Genentech, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
No active infection
At least one bi-dimensionally measurable nodal lesion, defined as >1.5 cm in its longest dimension, or one bi-dimensionally measurable lesion, defined as >1.0 cm in its longest diameter by computed tomography (CT) scan, positivie emission tomography - computed tomography (PET- CT), or magnetic resonance imaging (MRI)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first study treatment to first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by investigator according to lugano criteria 2014 (min. 2 years for cohorts a1 - c or 1 year for cohorts d, e)
Awards & highlights

MorningSun Trial Summary

This trial will test a new drug, mosunetuzumab, on patients with certain types of non-Hodgkin's lymphoma. They will be testing how effective and safe the drug is, as well as how it is processed in the body.

Who is the study for?
This trial is for adults with certain types of non-Hodgkin's lymphoma who have measurable disease, adequate organ function, and no severe infections or recent major surgeries. Participants must not be pregnant, agree to use contraception, and have a performance status that allows daily activity. Those with HIV can join if stable on therapy. It excludes those with past CNS lymphoma, recent monoclonal antibody treatment, active hepatitis B/C or other significant diseases.Check my eligibility
What is being tested?
The study tests mosunetuzumab's effects on various B-cell malignancies when administered under the skin (subcutaneous). Some participants may also receive tocilizumab. The trial aims to understand how well mosunetuzumab works alone in different doses and its safety profile.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site, increased risk of infection due to immune system suppression, fatigue, nausea, fever and potential allergic reactions. Tocilizumab might cause infusion-related reactions and changes in blood pressure.

MorningSun Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I do not have any current infections.
Select...
I have a tumor that is larger than 1.5 cm or a lesion over 1.0 cm, confirmed by imaging.
Select...
I can take care of myself and am up and about more than half of my waking hours.

MorningSun Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study treatment to first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by investigator according to lugano criteria 2014 (min. 2 years for cohorts a1 - c or 1 year for cohorts d, e)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study treatment to first occurrence of disease progression, relapse, or death from any cause, whichever occurs first, as determined by investigator according to lugano criteria 2014 (min. 2 years for cohorts a1 - c or 1 year for cohorts d, e) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective response rate (ORR), defined as the proportion of participants with a complete metabolic response (CMR) or partial response (PR), as determined by the investigator according to the Lugano Criteria 2014 (Cohorts C, D, and E)
Progression-free survival (PFS) rate at 24 months after the first study treatment (Cohorts A1, A2, and B)
Secondary outcome measures
DOR for participants with best response of CMR (all cohorts)
Duration of complete response (DoCR) (all cohorts)
Duration of response (DOR) (all cohorts)
+7 more

Side effects data

From 2017 Phase 4 trial • 59 Patients • NCT02034474
11%
Low ANC
5%
nausea
5%
Inpatient admission
5%
fatigue
5%
agranulocytosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tocilizumab
Placebo

MorningSun Trial Design

5Treatment groups
Experimental Treatment
Group I: Cohort EExperimental Treatment2 Interventions
Participants with R/R Richter's transformation (RT), or R/R transformed follicular lymphoma (tFL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Group II: Cohort DExperimental Treatment2 Interventions
Participants with relapsed or refractory (R/R) mantle cell lymphoma (MCL) will receive SC mosunetuzumab monotherapy for up to 34 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Group III: Cohort CExperimental Treatment2 Interventions
Participants with untreated marginal zone lymphoma (MZL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Group IV: Cohort BExperimental Treatment2 Interventions
Elderly participants with untreated diffuse large B-cell lymphoma (DLBCL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first.
Group V: Cohort AExperimental Treatment2 Interventions
Participants with high tumor burden with untreated follicular lymphoma (FL) will receive SC mosunetuzumab monotherapy for up to 17 cycles or until radiographic disease progression, study discontinuation, or death, whichever occurs first. Participants that achieve complete or partial metabolic response will have the option of receiving maintenance therapy with mosunetuzumab every 8 weeks for 1 year.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tocilizumab
2012
Completed Phase 4
~1840

Find a Location

Who is running the clinical trial?

Genentech, Inc.Lead Sponsor
1,538 Previous Clinical Trials
567,396 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,234 Total Patients Enrolled

Media Library

Mosunetuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05207670 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Cohort E, Cohort B, Cohort C, Cohort D, Cohort A
Non-Hodgkin's Lymphoma Clinical Trial 2023: Mosunetuzumab Highlights & Side Effects. Trial Name: NCT05207670 — Phase 2
Mosunetuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05207670 — Phase 2

Frequently Asked Questions

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

How many participants are currently being welcomed into this clinical experiment?

"This research project necessitates 275 participants that fulfill the enrollment requirements. Genentech, Inc., is managing the trial with sites located in Medford, Iowa and Des Moines, Montana; namely Asante Rogue Regional Medical Center and Mission Blood and Cancer - MercyOne Cancer Center respectively."

Answered by AI

What risks does Tocilizumab pose to individuals?

"Our team at Power judged Tocilizumab to be moderately safe by awarding it a score of 2, given that there are some safety studies in the Phase 2 stage but none demonstrating efficacy."

Answered by AI

Are additional participants still being welcomed into this investigation?

"Clinicaltrials.gov reveals that this research is still in need of volunteers, with the initial posting taking place on February 1st 2022 and a recent edit made on November 8th 2022."

Answered by AI

Has this trial been extended to multiple sites across the US?

"Currently, 36 locations are participating in this clinical trial. These sites span from Medford to Des Moines and Great Falls etcetera. To minimize the burden of traveling should you decide to take part, we recommend selecting a clinic that is closest to your home address."

Answered by AI
~230 spots leftby Jul 2028