REACT-01: Reversing Autoimmunity Through Cell Therapy

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)

A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have their T cells collected. The T cells will then be bioengineered into a CAR T cell that targets circulating and tissue residing B cells.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus
• Intervention / Treatment: Biological: SCRI-CAR19v3

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Shaun Jackson, MD; Phone Number: 206-987-3897; Email: Shaun.Jackson@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Contact: Shaun Jackson, MD; Phone Number: 206-884-7322; Email: cbdcintake@seattlechildrens.org
      • Principal Investigator: Shaun Jackson, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCRI-CAR19v3; Single infusion of SCRI-CAR19v3	Biological: SCRI-CAR19v3; Single infusion of SCRI-CAR19v3

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product.	28 days post-infusion
Rate of SCRI-CAR19v3 Manufacturing Success	We will measure the number of successfully manufactured SCRI-CAR19v3 products.	28 days

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Investigators: Study Chair: Shaun Jackson, MD, Seattle Children's Hospital; Study Director: Colleen Annesley, MD, Seattle Children's Hospital; Study Director: Corinne Summers, MD, Seattle Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 16, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2041

Study Registration Dates

• First Submitted: June 13, 2024
• First Submitted That Met QC Criteria: June 13, 2024
• First Posted (Actual): June 18, 2024

Study Record Updates

• Last Update Posted (Actual): December 12, 2025
• Last Update Submitted That Met QC Criteria: December 5, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Lupus; SLE; Systemic Lupus Erythematosus; CAR T cells
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: REACT-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No