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Mosunetuzumab

Phase 2

Diffuse Large B-Cell Lymphoma (DLBCL) | Small molecule | Oncology |Adaptive Biotechnologies Corporation|Last Updated: Oct 20, 2025

Target and mechanism

Molecular targetMS4A1, CD3E, CD3G, CD3D
Target classBinding Agent
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Mosunetuzumab · 1 trial · 1 indication

Phase 2 1
NCT06828991A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHPDiffuse Large B-Cell Lymphoma (DLBCL)
RECRUITING40 Analytics
PHASE2RECRUITING
A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP
Diffuse Large B-Cell Lymphoma (DLBCL)Unlock trial analytics

Study Endpoints

Primary Endpoints

ctDNA clearance rate after mosunetuzumab treatment
From the beginning to the end of mosunetuzumab treatment at 18 weeks

The primary endpoint of the trial is the ctDNA clearance rate after mosunetuzumab treatment among the subset of patients in a PET/CT CR but with ctDNA+ at the end of 6 cycles of R-pola-mini-CHP. The rate will be calculated as the number of subjects ctDNA- after mosunetuzumab treatment among all patients treated with mosunetuzumab as part of the Fleming two-stage design.

Secondary Endpoints

Objective response rate and complete response rate of pola-R-mini-CHP
From enrollment to the end of pola-R-mini-CHP treatment at 18 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ctDNA positiveEXPERIMENTALPatients who have achieved a radiographic complete response (CR) on PET/CT, but have detectable ctDNA at the end of treatment with pola-R-mini-CHP will receive 6 cycles of mosunetuzumab consolidation. Patients who have achieved a CR with undetectable ctDNA will be observed. Patients with a partial response on PET/CT will be managed per protocol.

Interventions

NameTypeDescription
MosunetuzumabDRUGMosunetuzumab consolidation therapy will consist of 6 cycles of IV mosunetuzumab at the standard ramp-up dosing (Day 1 1mg, Day 8 2mg, D15 60mg, C2D1 60mg, and 30mg on day 1 of the subsequent 21-day cycles)
ClonoSEQDEVICEPatients with detectable ClonoSEQ at C6D1 who have a PET/CT that shows a CR will receive mosunetuzumab
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Eligibility Criteria

Age Range70 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria 1. Patients aged greater than or equal to 70 years of age who are ineligible for full-intensity chemoimmunotherapy at the discretion of the treating investigator. If between the ages of 70-79, the reason for ineligibility should be documented in a clinical note. If 80 or older, t...

Countries:United States
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Recent Changes (Last 90 Days)

LOWMay 24, 2026NCT06828991studyFirstPostDate: changed

Frequently asked questions about Mosunetuzumab

What is Mosunetuzumab used for in Diffuse Large B-Cell Lymphoma?

Mosunetuzumab is being studied as a consolidation treatment for older patients with Diffuse Large B-Cell Lymphoma (DLBCL) who have detectable circulating tumor DNA (ctDNA) at the end of treatment with Pola-R-mini-CHP. It is an investigational therapy currently in Phase 2 clinical development.

What does Mosunetuzumab target?

Mosunetuzumab targets MS4A1, CD3E, CD3G, and CD3D. It is classified as a binding agent, designed to interact with these molecular targets in the context of B-cell lymphoma treatment.

Who is developing Mosunetuzumab?

Mosunetuzumab is being developed by Adaptive Biotechnologies Corporation, a company traded on the stock exchange under the ticker ADPT. The drug is currently in Phase 2 clinical trials for Diffuse Large B-Cell Lymphoma.

What phase is Mosunetuzumab in?

Mosunetuzumab is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being evaluated in an ongoing clinical trial for patients with Diffuse Large B-Cell Lymphoma.

What clinical trials is Mosunetuzumab in?

Mosunetuzumab is being evaluated in clinical trial NCT06828991, a Phase 2 study recruiting older patients with Diffuse Large B-Cell Lymphoma who have detectable ctDNA after Pola-R-mini-CHP treatment. The trial is enrolling 40 participants in the United States.

Is Mosunetuzumab the same as CHEMBL4297788?

Yes, Mosunetuzumab is also known by the ChEMBL identifier CHEMBL4297788. This identifier is used in chemical and biological databases to reference the same compound.