Recruiting
Phase 1

Cell Therapy

Sponsor:

Seattle Children's Hospital

Code:

NCT06465147

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Not accepted

Interventions

SCRI-CAR19v3

Study Details

Brief 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 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

Study ID

NCT06465147

Start date

Dec 16, 2024

Status verified date

Dec, 2025

Completion date

Oct, 2041

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 30

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Interventions

SCRI-CAR19v3

Single infusion of SCRI-CAR19v3

Primary outcome measure

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [ Time Frame: 28 days post-infusion ]
  • Rate of SCRI-CAR19v3 Manufacturing Success [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Shaun Jackson, MD

206-987-3897Shaun.Jackson@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Shaun Jackson, MD

206-884-7322cbdcintake@seattlechildrens.org

Principal Investigator:

Shaun Jackson, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Dec 12, 2025

Last verified

Dec, 2025

Keywords

  • CAR T cells
  • Lupus
  • Systemic Lupus Erythematosus
  • SLE

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2025-12-12.