Reversing autoimmunity in lupus using cell therapy

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 phase 1, open-label study focuses on pediatric and young adult participants with treatment-refractory Systemic Lupus Erythematosus (SLE). The study aims to evaluate the safety, feasibility, and efficacy of genetically modified T cell products derived from peripheral blood mononuclear cells (PBMC) that express a CD19 specific chimeric antigen receptor (CAR). Participants will undergo apheresis to collect their T cells, which will then be bioengineered to target B cells involved in the autoimmune response. The study is designed to provide insights into a novel therapeutic approach for a challenging condition.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male and female subjects aged between 2-30 years old. The first 3 subjects will be aged ≥ 17. The FDA will review safety data to determine if the age can be lowered first to ≥ 12 then, following the treatment of 3 further subjects aged 12-17, to ≥ 2
* Serologically active Systemic Lupus Erythematosus that is refractory to treatment
* Able to tolerate apheresis or already has an apheresis product available for use in manufacturing.
* ≥ 24 weeks post last Rituximab or related B cell depleting therapy
* ≥ 12 weeks post last Belimumab / Anifrolumab therapy
* ≥ 4 weeks post last calcineurin inhibitor treatment
* For subjects receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment
* For subjects receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment
* Adequate organ function
* Adequate laboratory values
* Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
* Subjects must be willing to remain within 1 hour's drive of Seattle Children's Hospital for 4 weeks following CAR T cell infusion.
* Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria:

* History or presence of active CNS lupus or other CNS disease
* Kidney dysfunction requiring renal replacement therapy
* Pregnant or breastfeeding
* Insufficient pulmonary reserve including history of COPD, \>10 pack year smoking history or SLE lung disease with hypoxia at rest with oxygen saturation ≤92% on room air
* Unable to tolerate repletion with any formulation of IgG.
* Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment.
* Prior solid organ transplantation.
* Presence of an active severe infection
* Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol

Where it's running

• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting

Study contacts

• Study coordinator: Shaun Jackson, MD
• Email: Shaun.Jackson@seattlechildrens.org
• Phone: 206-987-3897

Similar studies

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

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• Biomarker tests in adults with lupus to see how kidney disease changes over time

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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.