REACT-01: Reversing Autoimmunity Through Cell Therapy

NCT ID: NCT06465147

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-16
• Study Completion Date: 2041-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Group Type: EXPERIMENTAL

SCRI-CAR19v3

Intervention Type: BIOLOGICAL

Single infusion of SCRI-CAR19v3

Interventions

SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Intervention Type: BIOLOGICAL

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 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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seattle Children's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Colleen Annesley

Medical Director & Co-Chief Medical Officer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun Jackson, MD

Role: STUDY_CHAIR

Seattle Children's Hospital

Colleen Annesley, MD

Role: STUDY_DIRECTOR

Seattle Children's Hospital

Corinne Summers, MD

Role: STUDY_DIRECTOR

Seattle Children's Hospital

Locations

Seattle Children's Hospital

Seattle, Washington, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shaun Jackson, MD

Role: CONTACT

Shaun.Jackson@seattlechildrens.org

206-987-3897

Facility Contacts

Shaun Jackson, MD

Role: primary

cbdcintake@seattlechildrens.org

206-884-7322

Other Identifiers

REACT-01

Identifier Type: -

Identifier Source: org_study_id