Actively Recruiting
REACT-01: Reversing Autoimmunity Through Cell Therapy
Led by Seattle Children's Hospital · Updated on 2025-12-12
12
Participants Needed
1
Research Sites
876 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
REACT-01: Reversing Autoimmunity Through Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged between 2-30 years old
- 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
- At least 24 weeks post last Rituximab or related B cell depleting therapy
- At least 12 weeks post last Belimumab or Anifrolumab therapy
- At least 4 weeks post last calcineurin inhibitor treatment
- Stable dose of non-calcineurin immunosuppressive therapy for at least 8 weeks before enrollment
- Stable dose of corticosteroid therapy for at least 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
- Willingness to stay within 1 hour's drive of Seattle Children's Hospital for 4 weeks following infusion
- Signed informed consent form for the study
You will not qualify if you...
- 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, more than 10 pack year smoking history, or SLE lung disease with low oxygen saturation at rest
- Unable to tolerate IgG replacement therapy
- Active or prior malignancy unless treated with no recurrence for less than 5 years
- Prior solid organ transplantation
- Presence of an active severe infection
- Any condition that the investigator believes would prevent participation in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
S
Shaun Jackson, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here