REACT-01: Reversing Autoimmunity Through Cell Therapy
ConditionSystemic Lupus Erythematosus
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age2-30
SponsorSeattle Children's Hospital
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
SCRI-CAR19v3
Biological/VaccineSingle infusion of SCRI-CAR19v3
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: SCRI-CAR19v3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product.
Time frame
28 days post-infusion2
Rate of SCRI-CAR19v3 Manufacturing Success
We will measure the number of successfully manufactured SCRI-CAR19v3 products.
Time frame
28 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov