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NCT06333483

A Study of CD19 Targeted CAR T Cell Therapy in Patients With Severe, Refractory Systemic Lupus Erythematosus (SLE)

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
Autolus Limited·Phase 1·ClinicalTrials.gov·biologicalRecruiting
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Study focus
Disease/Condition
Systemic Lupus Erythematosus
Drug/Device/Intervention
Obecabtagene autoleucel (obe-cel)
Study type
Interventional
Intervention type
biological
Sponsor & location
Primary sponsor
Autolus Limited
Location
London, United Kingdom
Timeline & enrollment
Phase
Phase 1
Start date
Feb 02, 2024
End date
Oct 01, 2025
Enrollment
12 participants
Primary outcome

Dose limiting toxicities,Adverse events

Summary

This is a Phase I 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.

ICD-10 classifications
Systemic lupus erythematosusSystemic lupus erythematosus, unspecifiedLupus erythematosusSystemic lupus erythematosus with organ or system involvementOther forms of systemic lupus erythematosus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06333483
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06333483 through Pure Global AI's free database. This Phase 1 trial is sponsored by Autolus Limited and is currently Recruiting. The study focuses on Systemic Lupus Erythematosus. Target enrollment is 12 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.