RecruitingPhase 1NCT06333483

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus


Sponsor

Autolus Limited

Enrollment

18 participants

Start Date

Feb 2, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.


Eligibility

Min Age: 12 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Obecabtagene autoleucel (obe-cel) for people with systemic lupus erythematosus. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 12 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALObecabtagene autoleucel (obe-cel)

Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a single dose of obe-cel


Locations(6)

Hospital Universitari Vall Hebrón

Barcelona, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Addenbrookes Hospital

Cambridge, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Great Ormond Street Hospital

London, United Kingdom

Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

Manchester, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06333483


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