ICI And Response In Autoimmunity

Overview

About this study

The primary aims of this study are to determine the immunopathology and molecular mechanisms of clinically-used PD-1 and PDL1 blockade mediated autoimmune diseases, and to investigate how dysregulation of PD-1 signaling contributes to IA-irAE and seronegative RA in human subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

For healthy subjects:

Inclusion Criteria:

  • No recorded disease diagnosis

For irAe patients:

Inclusion Criteria:

  • Adults age 18 years or older

  • Any concomitant malignancy being treated with and PD-1 or PD-L1 inhibitor as monotherapy or adjuvant therapy

    • PD-1/PD-L1 inhibitors: pembrolizumab, nivolumab, cemiplimab, atezolimumab, durvalumab, or avelumab

  • Presence of inflammatory arthritis defined by:

    • Provider documents inflammatory arthritis in one or more large or small joints AND

    • At least one or more of the following:

      • Elevated Inflammatory markers

  • Supportive imaging and/or supportive synovial fluid analysis OR presence of other irAE manifestation with disease activity of CTCAE ≥ 1.

 Exclusion Criteria:

  • Active infection

  • Prior history of any rheumatic disease

  • Any exposure to B-cell depleting therapy (e.g., Rituximab)

  • Active use of high dose prednisone (≥30 mg daily) or steroid equivalent

For ICI-control patients:

Inclusion Criteria:

  • Adults age 18 years or older

  • Any concomitant malignancy being treated with any PD-1 or PD-L1 inhibitor as monotherapy or adjuvant therapy

    • PD-1/PD-L1 inhibitors: pembrolizumab, nivolumab, cemiplimab, atezolimumab, durvalumab, or avelumab

 Exclusion Criteria:

  • Active infection

  • Prior history of any rheumatic disease

  • Any exposure to B-cell depleting therapy (e.g., Rituximab)

  • Aany symptom of inflammatory arthritis within 6 months of initiation of ICI therapy

For RA and other matched rheumatic patients:

Inclusion Criteria:

  • Adults age 18 years or older

  • Provider documented rheumatoid arthritis (meet 2010 ACR/EULAR classification criteria of RA)

  • Provider documented other rheumatic disorders matched with the irAE patient

Exclusion Criteria:

  • Active infection

  • Positive for anti-CCP or anti-ACPA

  • Any cancer diagnosis

  • Active use of high dose prednisone (≥30 mg daily) or steroid equivalent

  • Any exposure to B-cell depleting therapy (e.g., Rituximab)

For seropositive RA (identified from IRB 18-006677, Dr. John Davis, PI, included PMBC biobank plus additional new recruitment for controls, n=40 + 40):

     Inclusion Criteria:

  • Adults age 18 years or older

  • Provider documented rheumatoid arthritis (meet 2010 ACR/EULAR classification criteria of RA)

  • Positive for anti-CCP or anti-ACPA

     Exclusion Criteria:

  • Active Infection

  • Any cancer diagnosis

  • Any exposure to B-Cell depleting therapy (e.g., Rituximab)

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

 

Eligibility last updated 08/18/2025. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Hu Zeng, Ph.D.

Open for enrollment

Contact information:

Amber Woltzen

Woltzen.Amber@mayo.edu

More information

Publications

Publications are currently not available