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XmAb657

Phase 1

Idiopathic Inflammatory Myopathies | Monoclonal antibody | Immunology |Xencor, Inc.|Trials Updated: Aug 3, 2026

XmAb657 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2025

XmAb657 target and mechanism

Molecular targetCD19
Target classB-cell
ModalityMonoclonal antibody

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

XmAb657 clinical trials

XmAb657 · 1 trial · 4 indications

Phase 1 1
NCT07284797A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune DiseasesHealthy
RECRUITING60 Analytics
PHASE1RECRUITING
A Phase 1 Open-label Study to Evaluate Safety in Healthy Participants and Participants With Autoimmune Diseases
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Through Week 52

Secondary Endpoints

Serum concentration of XmAb657
Through Week 52
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALXmAb657 administered SC

Interventions

NameTypeDescription
XmAb657BIOLOGICALBiological
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: Healthy participants - Adult participants in good health Idiopathic inflammatory myopathy (IIM) participants - Adult participants that meet the 2017 European Alliance of Association Rheumatology (EULAR)/American College of Rheumatology (ACR) Classification Criterion for IIM Sy...

Countries:Australia
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Recent Changes (Last 90 Days)

LOWAug 3, 2026NCT07284797lastUpdatePostDate: changed
LOWAug 3, 2026NCT07284797lastUpdatePostDate: changed

Frequently asked questions about XmAb657

What is XmAb657?

XmAb657 is an investigational monoclonal antibody developed by Xencor, Inc. for idiopathic inflammatory myopathies, a group of autoimmune muscle disorders. It is in Phase 1 clinical development and has not been approved by any regulatory agency. Xencor is studying it in immunology, with a single active trial currently recruiting participants.

What does XmAb657 target?

XmAb657 targets CD19, a protein found on the surface of B cells. By binding CD19, the antibody is designed to engage B cells, the immune cell class implicated in antibody-driven autoimmune conditions such as idiopathic inflammatory myopathies. CD19-directed approaches aim to reduce the B-cell contribution to autoimmune disease activity.

Who makes XmAb657?

Xencor, Inc. is developing XmAb657. Xencor is a clinical-stage biopharmaceutical company traded on the Nasdaq under the ticker XNCR. The company discovered and is running the Phase 1 program for XmAb657 in idiopathic inflammatory myopathies and related autoimmune conditions.

What phase is XmAb657 in?

XmAb657 is in Phase 1 clinical development. It is investigational and has not been approved for any indication. The Phase 1 program is an open-label study evaluating safety in healthy participants and participants with autoimmune diseases, and it is currently recruiting.

What clinical trials is XmAb657 in?

XmAb657 is being studied in one active clinical trial, NCT07284797, titled a Phase 1 open-label study to evaluate safety in healthy participants and participants with autoimmune diseases. The trial is recruiting, plans to enroll 60 participants, and is being conducted in Australia in adults 18 years and older.

What is XmAb657 used for in idiopathic inflammatory myopathies?

XmAb657 is being developed as a potential treatment for idiopathic inflammatory myopathies, a group of autoimmune conditions affecting muscle. It is investigational and not approved for this or any other use. The Phase 1 trial also enrolls participants with systemic sclerosis and Sjogren's disease alongside healthy volunteers.