CAR T Cell Therapy for Systemic Lupus Erythematosus

REACT-01: Reversing Autoimmunity Through Cell Therapy

Recruiting Phase 1 Interventional Study
Systemic Lupus Erythematosus
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
2 – 30
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Seattle Children's Hospital · Other
Who this trial is looking for

This trial is looking for children and young adults with difficult-to-treat Systemic Lupus Erythematosus. Participants will have their T cells collected and modified to target specific immune cells in their body.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 2 and 30 years old.
  • I have been diagnosed with Systemic Lupus Erythematosus that doesn't respond to treatment.
  • I can tolerate apheresis.
  • I am at least 24 weeks since my last Rituximab treatment.
  • I am at least 12 weeks since my last Belimumab or Anifrolumab treatment.
  • I am at least 4 weeks since my last calcineurin inhibitor treatment.
  • I am willing to stay close to Seattle Children's Hospital for 4 weeks after treatment.
  • I can use effective contraception if needed.

You may not be able to join if

  • I have active CNS lupus or any CNS disease.
  • I need renal replacement therapy for kidney dysfunction.
  • I am pregnant or breastfeeding.
  • I have significant lung disease or a history of smoking.
  • I cannot tolerate repletion with IgG.
  • I have had active cancer in the last 5 years.
  • I have had a solid organ transplant.
  • I have an active severe infection.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This is a phase 1, open-label, non-randomized study enrolling pediatric and young adult research participants with treatment-refractory Systemic Lupus Erythematosus (SLE), to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to express CD19 specific chimeric antigen receptor (CAR…
Trial Locations
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Eligibility Criteria
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 Syst…
Contacts

Shaun Jackson, MD

206-987-3897

Shaun.Jackson@seattlechildrens.org

CONTACT