REACT-01: Reversing Autoimmunity Through Cell Therapy

Systemic Lupus Erythematosus Clinical Trial

Official title:

REACT-01: Reversing Autoimmunity Through Cell Therapy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06465147
• Other study ID #: REACT-01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: July 2024
• Est. completion date: July 2041

Study information

• Verified date: June 2024
• Source: Seattle Children's Hospital
• Contact: Shaun Jackson, MD
• Phone: 206-987-3897
• Email: Shaun.Jackson[@]seattlechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: July 2041
• Est. primary completion date: July 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 30 Years

Eligibility

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 remiain 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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Biological:
• SCRI-CAR19v3
Single infusion of SCRI-CAR19v3

Locations

Country	Name	City	State
United States	Seattle Children's Hospital	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Seattle Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	28 days post-infusion
Primary	Rate of SCRI-CAR19v3 Manufacturing Success	We will measure the number of successfully manufactured SCRI-CAR19v3 products.	28 days