No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
2 – 30
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
12 (estimated)
Sponsor
Seattle Children's Hospital · Other
Who this trial is looking for
This trial is looking for children and young adults with difficult-to-treat Systemic Lupus Erythematosus. Participants will have their T cells collected and modified to target specific immune cells in their body.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 2 and 30 years old.
I have been diagnosed with Systemic Lupus Erythematosus that doesn't respond to treatment.
I can tolerate apheresis.
I am at least 24 weeks since my last Rituximab treatment.
I am at least 12 weeks since my last Belimumab or Anifrolumab treatment.
I am at least 4 weeks since my last calcineurin inhibitor treatment.
I am willing to stay close to Seattle Children's Hospital for 4 weeks after treatment.
I can use effective contraception if needed.
You may not be able to join if
I have active CNS lupus or any CNS disease.
I need renal replacement therapy for kidney dysfunction.
I am pregnant or breastfeeding.
I have significant lung disease or a history of smoking.
I cannot tolerate repletion with IgG.
I have had active cancer in the last 5 years.
I have had a solid organ transplant.
I have an active severe infection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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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 Syst…
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
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