REACT-01: Reversing Autoimmunity Through Cell Therapy

NCT06465147 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: REACT-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Lupus Erythematosus

Keywords

CAR T cells; Lupus; Systemic Lupus Erythematosus; SLE

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

SCRI-CAR19v3

EXPERIMENTAL

Single infusion of SCRI-CAR19v3

Biological: SCRI-CAR19v3

Interventions

SCRI-CAR19v3 BIOLOGICAL

Single infusion of SCRI-CAR19v3

SCRI-CAR19v3

Eligibility Criteria

• Age: 2 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Shaun Jackson, MD

  Seattle Children's Hospital

  STUDY CHAIR

• Colleen Annesley, MD

  Seattle Children's Hospital

  STUDY DIRECTOR

• Corinne Summers, MD

  Seattle Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Shaun Jackson, MD

CONTACT

206-987-3897; Shaun.Jackson@seattlechildrens.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director & Co-Chief Medical Officer

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 18, 2024
• Study Start: December 16, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2041
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

US (1)