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New treatment option for Systemic Lupus Erythematosus
Official title REACT-01: Reversing Autoimmunity Through Cell Therapy
ClinicalTrials.gov ID: NCT06465147
What this study is testing
What is SCRI-CAR19v3?
SCRI-CAR19v3 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for systemic lupus erythematosus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 30
You may be able to join if
- Male and female people aged between 2-30 years old. The first 3 people will be aged ≥ 17. The FDA will review safety data to determine if the age can...
- 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
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- Male and female people aged between 2-30 years old. The first 3 people 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...
- 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 people receiving non-calcineurin immunosuppressive therapy, on a stable dose for ≥ 8 weeks before enrollment
- For people receiving corticosteroid therapy, on a stable dose for ≥ 2 weeks before enrollment
- Adequate organ function
- Adequate laboratory values
- people 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
- people 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.