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REACT-01: Reversing Autoimmunity Through Cell Therapy

NCT06465147 · Seattle Children's Hospital
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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.
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
Study design
Enrollment target: 12 participants
Allocation: na
Masking: none
Age groups: child, adult
Timeline
Starts: 2024-12-16
Estimated completion: 2041-10
Last updated: 2025-12-12
Interventions
Biological: SCRI-CAR19v3
Primary outcomes
  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (28 days post-infusion)
  • Rate of SCRI-CAR19v3 Manufacturing Success (28 days)
Sponsor
Seattle Children's Hospital · other
Contacts & investigators
ContactShaun Jackson, MD · contact · Shaun.Jackson@seattlechildrens.org · 206-987-3897
InvestigatorShaun Jackson, MD · study_chair, Seattle Children's Hospital
InvestigatorColleen Annesley, MD · study_director, Seattle Children's Hospital
InvestigatorCorinne Summers, MD · study_director, Seattle Children's Hospital
All locations (1)
Seattle Children's HospitalRecruiting
Seattle, Washington, United States
REACT-01: Reversing Autoimmunity Through Cell Therapy · TrialPath