REACT-01: Reversing Autoimmunity Through Cell Therapy

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT06465147
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • SCRI-CAR19v3 — BIOLOGICAL
    Single infusion of SCRI-CAR19v3

Study Details

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.

Key Dates

Start date
Dec 16, 2024
Status verified
Dec 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2041

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Shaun Jackson, MD
[email protected]
206-884-7322
Shaun Jackson, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Lupus (SLE)
By specialty
RheumatologyAutoimmune disease
By research site
Seattle Children's Hospital· Seattle, WA

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