NCT06465147RecruitingPhase 1
REACT-01: Reversing Autoimmunity Through Cell Therapy
Source: ClinicalTrials.gov · Last updated 12 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 12 (estimated)
- First submitted
- 13 Jun 2024
- Start date
- Dec 2024
- Primary completion date
- Oct 2028
- Lead sponsor
- Seattle Children's Hospital
- Diseases
- Lupus (SLE)
- NCT number
- NCT06465147
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 12
- From Dec 2024 to the primary completion date, Oct 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Kidney dysfunction requiring renal replacement therapy
- Prior solid organ transplantation.
Other illness
- 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
Age
- Active or prior malignancy, unless the malignancy was treated and there is no evidence of recurrent disease \<5 years from enrollment.
Other
- Pregnant or breastfeeding
- Unable to tolerate repletion with any formulation of IgG.
Who the study is looking for
- 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
Age in the registry: 2 years to 30 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.