Testing a CAR T cell therapy in young people with lupus
Tests SCRI-CAR19v3, modified immune cells, in young people with lupus that resists treatment.
Plain-language title generated from the registry record
Registry title: REACT-01: Reversing Autoimmunity Through Cell Therapy
Key facts
- Where
- Seattle, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 2 and 30 years old?
Source: NCT06465147, who can take part
Where in United States
- Seattle Children's HospitalSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seattle Children's Hospital
- Trial code
- NCT06465147
- Record updated
- 12 December 2025
- Original description
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)Read full original descriptionShow less
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.
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: Kidney dysfunction requiring renal replacement therapy; Prior solid organ transplantation; History or presence of active CNS lupus or other CNS disease; 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; 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; Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease <5 years from enrollment; Pregnant or breastfeeding; Unable to tolerate repletion with any formulation of IgG.