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REACT-01: CAR T-cell Therapy for Lupus

This study, REACT-01, is testing a new treatment called SCRI-CAR19v3 for children and young adults (ages 2-30) with Systemic Lupus Erythematosus (SLE), an autoimmune disease, that hasn't responded to other treatments. The study aims to see how safe SCRI-CAR19v3 is and if it can be successfully made for each patient. SCRI-CAR19v3 is a type of CAR T-cell therapy, where your own T cells are collected, modified in a lab to target certain B cells, and then given back to you. This is a small study, planning to enroll 12 participants. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1, open-label study, meaning both you and the study team will know what treatment you are receiving. It is not randomized, and plans to enroll 12 participants.
What's involved
Your T cells will be collected through a process called apheresis. These cells will then be modified in a lab.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for 28 days after receiving the SCRI-CAR19v3 infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06465147

REACT-01: Reversing Autoimmunity Through Cell Therapy

Recruiting
PHASE1Ages 2–30InterventionalTreatment
Seattle Children's Hospital
~12 participants
Updated 2025-12-12 on ClinicalTrials.gov
What's tested:SCRI-CAR19v3

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Measured over 28 days post-infusion
+1 more outcome measured

Conditions

Systemic Lupus Erythematosus

Explore related trials

Systemic Lupus Erythematosus

Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Shaun Jackson, MD · STUDY_CHAIR · Seattle Children's Hospital
  • Colleen Annesley, MD · STUDY_DIRECTOR · Seattle Children's Hospital
  • Corinne Summers, MD · STUDY_DIRECTOR · Seattle Children's Hospital

Who to contact

Shaun Jackson, MD
[email protected]
206-987-3897
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]28 days post-infusion

    The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product.

  • Rate of SCRI-CAR19v3 Manufacturing Success28 days

    We will measure the number of successfully manufactured SCRI-CAR19v3 products.