Phase 1 safety test of XmAb657 in healthy adults and people with myositis, scleroderma, or Sjögren's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label Phase 1 trial that administers XmAb657 subcutaneously to cohorts of healthy adults and adults who meet established classification criteria for idiopathic inflammatory myopathies, systemic sclerosis, or primary Sjögren's syndrome. The study is designed to collect safety and tolerability data and to measure pharmacokinetics, pharmacodynamics, and immunogenicity signals. Standard exclusion criteria apply, including recent major surgery, active or recurrent infections, untreated latent tuberculosis, recent cancer, and uncontrolled major organ disease. The sponsor is Xencor, Inc., and dosing and follow-up occur at the listed investigative site in Melbourne.

Why it matters

Who can join: the full rules

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

Systemic sclerosis (SSc) participants - Adult participants that meet the 2013 ACR/EULAR Classification Criteria for SSc

Sjogren's Disease participants that meet the 2016 ACR/EULAR Classification Criteria for Primary Sjogren's Syndrome

All participants - Use of highly effective methods of contraception

Exclusion Criteria:

* Major surgery within 12 weeks prior to dosing or planned within the study
* Recurrent infections or active clinically significant infection
* Active or untreated latent tuberculosis
* Cancer or history of cancer or lymphoproliferative disease within the previous 5 years
* Uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, or gastrointestinal disease

Note: Additional, more specific inclusion/exclusion criteria are defined in the protocol.

Where it's running

• Xencor Investigative Site
  Melbourne, Australia Recruiting

Study contacts

• Study coordinator: 657-01 Study Information
• Email: 657-aiinfo@xencor.com

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Test of HBM7020 in healthy adults and adults with autoimmune diseases

  This first-in-human study tests whether HBM7020 is safe and how it acts in the body for people with autoimmune diseases like RA, SLE, Sjögren's, and SSc compared with healthy volunteers.

  Recruiting Phase 1 Otsuka Pharmaceutical Development & Commercialization, Inc. · Brisbane, Queensland · NCT07649265

• AZD0120 CD19/BCMA CAR T-cell therapy for systemic sclerosis, inflammatory myopathies, and difficult-to-treat rheumatoid arthritis

  This trial will try a dual-targeting CD19/BCMA CAR T-cell treatment (AZD0120) in adults with systemic sclerosis, idiopathic inflammatory myopathies, or difficult-to-treat rheumatoid arthritis to see if it is safe and well tolerated.

  Recruiting at 5 sites Phase 1/2 AstraZeneca · Tucson, Arizona and 26 other locations · NCT07295847

• Imaging in Inflammatory Heart Diseases linked to autoimmune disorders

  This study tests how well multimodality imaging (CMR, echocardiography, and PET) detects inflammation in people with suspected inflammatory heart or autoimmune rheumatic diseases.

  Recruiting Assistance Publique - Hôpitaux de Paris · Paris · NCT07077304

• Using engineered natural killer cells to treat immune-mediated diseases

  This study is testing a new type of cell therapy called NKX019 to see if it can safely help people with immune-related diseases like systemic sclerosis and certain types of myopathies.

  Recruiting at 12 sites Phase 1/2 Nkarta, Inc. · Los Angeles, California and 11 other locations · NCT06733935

• Targeted CAR-T therapy for autoimmune diseases

  This study is testing a new type of CAR-T therapy to see if it can help people with active autoimmune diseases feel better and manage their symptoms.

  Recruiting Early Phase 1 Nanjing Bioheng Biotech Co., Ltd. · Bengbu, Anhui · NCT06548607

• Telitacicept for primary Sjögren’s with interstitial lung disease

  This study tests whether Telitacicept helps people with primary Sjögren’s syndrome and interstitial lung disease compared with standard immunosuppressants.

  Recruiting Peking University People's Hospital · Beijing · NCT07843381

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.