Systemic Lupus ErythematosusPhase 1NCT06465147
REACT-01: Reversing Autoimmunity Through Cell Therapy
A Phase 1 study testing SCRI-CAR19v3 in people with Systemic Lupus Erythematosus, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 2 to 30 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- SCRI-CAR19v3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2024to Oct 2041
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Shaun Jackson, MD, 206-884-7322, cbdcintake@seattlechildrens.org
Shaun Jackson, MD
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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- SCRI-CAR19v3
- Keywords
- CAR T cells, Lupus, Systemic Lupus Erythematosus, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRI-CAR19v3Biological
Single infusion of SCRI-CAR19v3
| Study group | Role | What they receive |
|---|---|---|
| SCRI-CAR19v3 | Experimental | Single infusion of SCRI-CAR19v3 Receives: Biological: SCRI-CAR19v3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days post-infusion
Rate of SCRI-CAR19v3 Manufacturing Success
We will measure the number of successfully manufactured SCRI-CAR19v3 products.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start16 Dec 2024
- Primary completionOct 2028 (estimated)
- Study completionOct 2041 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Annesley, Seattle Children's Hospital
- Investigators
- Shaun Jackson, MD, Study chair, Seattle Children's HospitalColleen Annesley, MD, Study director, Seattle Children's HospitalCorinne Summers, MD, Study director, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465147
- Sponsor's protocol ID
- REACT-01
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2024
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REACT-01: Reversing Autoimmunity Through Cell Therapy
- ClinicalTrials.gov ID
- NCT06465147
- Acronym / sponsor ID
- REACT-01
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- CAR T cells, Lupus, Systemic Lupus Erythematosus, SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Oct 2041 (estimated)
- First posted
- 18 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRI-CAR19v3 | Experimental | Biological: SCRI-CAR19v3Single infusion of SCRI-CAR19v3 |
Who may qualify
- Ages
- 2 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SCRI-CAR19v3Single infusion of SCRI-CAR19v3 | Biological | SCRI-CAR19v3 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 28 days post-infusion
The investigators will assess and described the type, frequency, severity, and duration of adverse events associated with the CAR T cell product.
Rate of SCRI-CAR19v3 Manufacturing Success
Time frame: 28 days
We will measure the number of successfully manufactured SCRI-CAR19v3 products.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaun Jackson, MD study chair
Seattle Children's Hospital
Colleen Annesley, MD study director
Seattle Children's Hospital
Corinne Summers, MD study director
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCRI-CAR19v3 in people with Systemic Lupus Erythematosus, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shaun Jackson, MD (206-987-3897, Shaun.Jackson@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 28 days post-infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025; AzTrials last refreshed its copy on 31 Oct 2026.