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XmAb657

Phase 1

Healthy | Monoclonal antibody | Immunology |Xencor, Inc.|Last Updated: Aug 3, 2026

Target and mechanism

Molecular targetCD19
Target classProtein
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

Clinical trial landscape

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 used for?

XmAb657 is an investigational monoclonal antibody being developed for autoimmune diseases, including idiopathic inflammatory myopathies, systemic sclerosis, and Sjögren's disease. It is currently being studied in healthy participants as part of a Phase 1 clinical trial to evaluate its safety.

What does XmAb657 target?

XmAb657 targets CD19, a protein found on the surface of B cells. By binding to CD19, the antibody is designed to modulate B-cell activity, which is relevant to autoimmune conditions where B cells contribute to disease pathology.

Who is developing XmAb657?

XmAb657 is being developed by Xencor, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol XNCR. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety.

What phase is XmAb657 in?

XmAb657 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess safety in healthy individuals and those with autoimmune diseases.

What clinical trials is XmAb657 in?

XmAb657 is being evaluated in a Phase 1 open-label trial with the identifier NCT07284797. This study is recruiting 60 participants in Australia to assess safety in healthy volunteers and individuals with autoimmune conditions, including idiopathic inflammatory myopathies, systemic sclerosis, and Sjögren's disease.