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CAR T-cell Therapy

Cell Therapy for Lupus

Phase 1
Waitlist Available
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serologically active Systemic Lupus Erythematosus that is refractory to treatment
Male and female subjects aged between 2-30 years old
Must not have
History or presence of active CNS lupus or other CNS disease
Kidney dysfunction requiring renal replacement therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Summary

This trial is enrolling children and young adults with Systemic Lupus Erythematosus to test the safety and effectiveness of using genetically modified T cells to target specific cells in the body. The

Who is the study for?
This trial is for children and young adults with severe Systemic Lupus Erythematosus (SLE) that hasn't improved with treatment. Participants will have their T cells collected and modified to target B cells related to SLE.
What is being tested?
The study tests a new therapy called SCRI-CAR19v3, where participants' own T cells are engineered to fight lupus by targeting CD19 on B cells. It's an early-stage trial focusing on safety and how well the treatment works.
What are the potential side effects?
Since this is a phase 1 trial primarily assessing safety, specific side effects of SCRI-CAR19v3 are not detailed but may include immune reactions, infusion-related symptoms, or other unforeseen issues due to genetic modification.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lupus is active and not responding to current treatments.
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I am between 2 and 30 years old.
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I can undergo apheresis or already have an apheresis product ready for use.
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It has been over 4 weeks since my last calcineurin inhibitor treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have or had lupus or another disease affecting my brain.
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I need dialysis for my kidney condition.
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I have had a solid organ transplant.
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I am currently fighting a severe infection.
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I have lung problems due to COPD, heavy smoking, or SLE and need oxygen.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Rate of SCRI-CAR19v3 Manufacturing Success

Trial Design

1Treatment groups
Experimental Treatment
Group I: SCRI-CAR19v3Experimental Treatment1 Intervention
Single infusion of SCRI-CAR19v3

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
307 Previous Clinical Trials
5,218,397 Total Patients Enrolled
Shaun Jackson, MDStudy ChairSeattle Children's Hospital
Colleen Annesley, MDStudy DirectorSeattle Children's Hospital
4 Previous Clinical Trials
291 Total Patients Enrolled
~8 spots leftby Jul 2028
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