REACT-01: Reversing Autoimmunity Through Cell Therapy

Seattle Children's Healthcare System

Status and phase

Enrolling

Phase 1

Conditions

Systemic Lupus Erythematosus

Treatments

Biological: SCRI-CAR19v3

Study type

Interventional

Funder types

Other

Identifiers

NCT06465147

REACT-01

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

2 to 30 years old

Volunteers

No Healthy Volunteers

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